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Human Clinical Support

EuroMedica
 
Longevity By Nature

This special section of Natural Practitioner comes in response to the desire for a greater understanding of the research and history behind the products available to practitioners and their patients, and manufacturers wanting to offer the science that backs the effectiveness of their products.We have featured a similar section annually in Natural Practitioner’s sister publication, Nutrition Industry Executive magazine, since 2002, where it was designed to help manufacturers gain a better understanding of the ingredients and services available that can make their products stand out.

Companies and associations have responded to this opportunity with background information about the health concerns their products are intended to address, histories of the nutrients behind their products and details of research carried out. In order to bridge the gap between interested practitioners and these companies, we’ve also provided company addresses, phone numbers and website addresses to make obtaining additional information easier.

America’s Finest Incorporated

20 Lake Dr.
East Windsor, NJ 08520
Phone: (800) 350-3305
Email: info@afisupplements.com
Website: www.afisupplements.com

Review of Curcumin Studies

In recent times, substantial interest has been shown by both researchers and consumers in naturally derived health supplements for both preventive care and management of various health conditions. Today, when inflammation is recognized as the root cause of several chronic diseases affecting millions of people across all ages and races, focus has shifted to curcuminoids, outstanding anti-inflammatory and antioxidant agents, which have a long history of use in the Indian traditional medicinal system—ayurveda.

Curcuminoids are obtained from rhizomes of turmeric and occur as a mixture of three compounds: curcumin (dominant), demethoxy curcumin and bisdemethoxy curcumin. Sabinsa secured a patent on an optimized composition containing all the three curcuminoids described in U.S. patent 5861,415 for its brand Curcumin C3 Complex®. In last 15 years, Curcumin C3 Complex has been part of more than 60 research studies published in peer-reviewed journals, with several of them in a clinical setting. Growing scientific evidences have shown benefits of C3 Complex in several chronic inflammatory conditions such as arthritis, asthma, liver dysfunction, diabetes, obesity, oral lichen planus, Alzheimer’s disease and many more.

Recently a group of researchers published the effect of C3 Complex on the lipid profile in obese subjects in the peer-reviewed journal Phytotherapy Research showing the potential of curcumin in improving the lipid profile in obese subjects.1 

The study provided evidence regarding the benefits of C3 Complex in the management of obesity-related health conditions.Today obesity is one of the major health concerns in not only developed countries but also in developing countries largely attributed to changing dietary habits. For example, 30 percent of the population in Mexico is considered to be obese. Obesity is also recognized as a primary risk factor for several diseases such as diabetes, hyper lipidemia, cardiovascular disease and joint problems.

The above study was carried out as a randomized, doubleblind, crossover study on 30 obese subjects aged between 18-65 years for a period of four weeks. The subjects recruited for the study had BMI= 30, LDL cholesterol ranging between 130-190 mg/dl and no history of taking any lipid lowering drugs. The subjects were randomized to either one of the two treatment regimens receiving curcuminoids or placebo for 30 days before crossing over to receive an alternate regimen.

The subjects in the treatment group were provided with 500 mg of capsules Curcumin C3 Complex containing BioPerine® (patented extract from black pepper fruits), with 1 g dosage of curcuminoids to be taken every day. BioPerine has been clinically found to enhance the bioavailability of curcuminoids in earlier studies.

The results of the study showed C3 Complex supplementation (1 g/day) in obese subjects was associated with significant lowering of triglyceride levels. This lowering of triglyceride levels in obese subjects can lower down the chances of diseases such as cardiovascular disease and diabetes. The lowering of triglyceride levels was attributed to the insulin sensitizing effects of curcuminoids.Further, the study also showed that Curcumin-BioPerine supplementation was safe and well tolerated in obese subjects.Effects of triglyceride lowering can be beneficial in obesity, metabolic syndrome and cardiovascular diseases.

Also a dose of 1 g/day of C3 Complex was found effective in reducing oxidative stress burden.2 

In another study performed by Tufts University, the safety of composition of Curcumin C3 Complex and BioPerine was studied. The results showed that use of BioPerine and Curcumin C3 Complex is safe and unlikely to cause any significant interaction with drugs such as Midazolam (CYP3A substrate), flurbiprofen (CYP2C9) or paracetamol/acetaminophen (UGT and SULT substrate).3 

In a fourth study, University of Rochester researchers showed oral C3 Complex reduced the severity of radiation dermatitis in breast cancer patients receiving radiotherapy.4 

C3 Complex was also the active ingredient in an oral formulation tested for tolerability and efficacy for oral mucositis (resulting from chemotherapy involving doxorubicin) in a clinical trial involving pediatric patients.5 

In a randomized, double blind, placebo controlled trial on sulfur-mustard-induced chronic pruritus, the researchers concluded that C3 Complex was effective in reducing pruritus severity score and other parameters including on the levels of substance P and antioxidant enzymes.6 

These clinical trials are the most recent ones that were published on Curcumin C3 Complex in addition to several other earlier ones.

References: 

1 A Mohammadi et al. Phytotherapy Research.2013: 27(3): 374-37.

2 A Sahebkar et al. Phytother Res. 2013 Mar 15.Doi: 10.1002/ptr.4952. 

3 LP Volak et al. Br. J Clin Pharmacol. 2012: 75(2): 450-462.

4 JL Ryan et al., Radiat Res. 2013: 180(1):34-43.

5 S Elad et al., Altern Ther Health Med. 2013: 19(3):21-4.

6 Y Panahi et al., Br J Nutr., 2012, 108(7), 1272-9.

Humanetics Corporation

1550 Utica Ave. S., Ste. 770
Minneapolis, MN 55416
Fax: (952) 937-7667
Contact: Scott Steil
Phone: (651) 245-8733 • Email: scott@nutrabridge.com

Why 20-Year-Olds Burn Fat Better Than 40-Year-Olds— and What to do About it

It’s harder to lose weight as we get older.Is there any truth more universally accepted than this? It’s a source of perpetual frustration for so many of us who find that the same diet and exercise regimen that worked at age 20 increasingly fails us at 30, 40, 50 and beyond.

With rates of obesity and co-occurring health problems soaring, millions are looking for a better solution. Unfortunately, the weight management category is rife with unproven gimmicks and quick fixes. As consumers become increasingly savvy (and skeptical), science-backed products with demonstrated safety and efficacy rise in demand.

One of the key players in the fight against age-related weight gain: 7-Keto®. 7- Keto, or 7-oxo DHEA, is a naturally occurring substance in the human body. Levels of it dramatically decline as we age, taking our metabolisms and ability to burn fat down with it.1 By augmenting what the body naturally produces, supplementing 7- Keto levels simply replaces what time and nature takes away.2-4 

Adding the ingredient 7-Keto to a diet and exercise regimen has proven to safely elicit dramatic results, as evidenced in multiple published human clinical trials5,6—and supported by the more than one billion doses taken to date.

7-Keto’s impact is twofold: 1) it promotes fat loss, and 2) it increases users’ metabolisms.

Under double-blind, placebo-controlled research conditions, individuals who took 7- Keto in conjunction with a diet and exercise regimen lost triple the weight of those who relied on diet and exercise alone.7,8 Perhaps most strikingly, the majority of weight loss was fat loss.9-11 This fact distinguishes 7-Keto from “weight loss” supplements that simply promote water loss, thus creating a false perception of effectiveness.

7-Keto’s metabolic effect is truly the icing on the (fat-free) cake. Dieters have long been hampered by the double-edged sword of reduced calorie diets. On one hand, caloric reduction is a critical component of a weight loss regimen. On the other hand, cutting calories typically results in a slower metabolism, which thwarts weight loss efforts.Research shows that 7-Keto provides a clear solution to this dilemma. Individuals taking 7-Keto in conjunction with a reduced calorie diet were not only able to avoid the metabolic slump commonly associated with caloric reduction, but actually increased their metabolisms by 5.4 percent—without the use of stimulants.12 

7-Keto works by activating three key thermogenic enzymes that burn fat. It’s so effective, in fact, that it has been awarded a U.S. patent for metabolic rate increase and weight loss.13 Humanetics Corporation holds the patents for 7-Keto and has partnered with more than 100 quality companies offering more than 150 finished products.

Of course, the ability to burn fat like a 20- year-old and boost your metabolism is worthless if it’s not safe. That’s why 7-Keto’s stellar safety profile is so important. The two NDIs (new dietary ingredients) that have been successfully filed with the FDA (U.S. Food and Drug Administration) are critical in documenting rock solid safety for consumers.7-Keto has been subjected to rigorous safety testing and has been shown to be very safe when used as directed. In fact, not only did the clinical trials demonstrate no serious adverse side effects, but not a single serious adverse side effect has ever been reported—and more than one billion doses of 7-Keto have been taken.

With Baby Boomers beginning to enter the golden years and their children reaching middle age, the demand for safe, effective, non-gimmicky solutions to age-related weight gain will continue to increase.7-Keto is one proven solution that stands the test of time.

References: 

1 Marenich LP. Secretion of Testosterone, Epitestosterone, Androstenedione, and 7-Keto- Dehydroepiandrosterone in Healthy Men of Different Ages. Prob Endokrino.1979; 25(4):28-31.

2 Ergosteroids II: Biologically Active Metabolites and Synthetic Derivatives of Dehydroepiandrosterone.Steroids 1998; 63:158-165.

3 Induction of Thermogenic Enzymes by DHEA and Its Metabolites. In: Bellino F, Daynes RA, Hornsby PJ, Lavrin DH, Nestler JE, eds, Dehydroepiandrosterone (DHEA) and Aging. New York:New York Academy of Sciences; 1995:171-179.

4 Studies in Steroid Metabolism: Isolation and Characterization of New Urinary Studies. J Biol Chem 1954; 210:129-137.

5 A Randomized, Double-Blind, Placebo-Controlled Study of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Health Over Weight Adults. Curr Ther Res 2000; 61(7): 435-442.

6 The Effect of 7-Keto Naturalean™ on Weight Loss: A Randomized, Double Blind, Placebo Controlled Trial. Curr Ther Res 2002; 63(4): 263-272.

7 A Randomized, Double-Blind, Placebo-Controlled Study of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Health Over Weight Adults. Curr Ther Res 2000; 61(7):435-442.

8 The Effect of 7-Keto Naturalean on Weight Loss: A Randomized, Double Blind, Placebo Controlled Trial.Curr Ther Res 2002;63(4):263-272.

9 A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Thermogenic and Body Composition Effects of 3-Acetyl-7-Oxo- Dehydroepiandrosterone (7-Keto) Clinical Study Final Report, Humanetics Archives.

10 A Randomized, Double-Blind, Placebo-Controlled Study of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Health Over Weight Adults. Curr Ther Res 2000;61(7):435-442.

11 The Effect of 7-Keto Naturalean on Weight Loss: A Randomized, Double Blind, Placebo Controlled Trial. Curr Ther Res 2002;63(4):263-272.

12 HUM5007, a novel combination of thermogenic compounds, and 3-acetyl-7-oxo-dehydroepiandrosterone: each increases the resting metabolic rate of overweight adults. J Nutr Biochem 2007;18: 629-634.

13 U.S. Patent # 7,199,116.

Kamedis USA

15108 Alijon Ct.
Charlotte, NC 28278
Phone: (855) KAMEDIS • Fax: (305) 675-8389
Email: info@kamedis-usa.com
Website: www.kamedis-usa.com

Kamedis PSO Medis Body Cream Found to be an Effective Treatment for Psoriasis

Skin problems can be a big issue for people.According to the National Psoriasis Foundation, as many as 7.5 million Americans have psoriasis. Nearly 60 percent of those people reported that their disease is a large problem in their everyday lives.1 With the majority of patients thinking that their skin condition is a large problem in their lives, patients may be tempted to turn to traditional medicine, rather than making the choice to stick to an inside-out program. This poses a challenge to naturopathic doctors who are working to restore their patients to health.

Psoriasis is a frequent, chronic, inflammatory skin disorder characterized by erythematous plaques covered with thick, silvery scales, often accompanied by intense pruritus. Kamedis PSO Medis Body Cream is a bio-herbal treatment designed to exfoliate scaly skin and to calm irritation and redness. Herbal extracts included in the product induce attenuation of pro-inflammatory processes, thus reducing the redness and itchiness characterizing psoriatic lesions.

Kamedis studied the efficacy and safety of PSO Medis Body Cream. Results were given at a poster session during the 6th International Investigative Dermatology (IID) Joint Meeting in May 2013.

The clinical study was conducted at Dermatest Germany by Drs. Werner Voss and Gerrit Schlippe.

Methods 

To evaluate the effects of PSO Medis Body Cream, an open-label, self-controlled, interventional study was initiated, which included 20 subjects with psoriasis. Patients were instructed to apply the Body Cream on affected areas twice daily for six weeks. Psoriasis Area and Severity Index (PASI), pruritus, the proportion of patients with at least 50 percent and 75 percent reduction in PASI (PASI50, PASI75 respectively) were measured at each visit (days 0, 14, 28 and 42).2 

Results 

PASI steadily decreased throughout the study.

Of the patients with mild to moderate psoriasis (PASI<15, N=12), 67 percent achieved PASI50 and 50 percent achieved PASI75 after six weeks of treatment.

At the final visit, mean PASI decreased by 58 percent and mean pruritus (itching) score decreased by 83 percent (p < 0.001) compared to baseline.

• Reduction of at least 50 percent in pruritus score was reported by 10 out of 11 patients (92 percent).

• No worsening or any adverse events were reported.

• Eighty five percent (85 percent) of subjects were satisfied with the treatment.

Conclusions 

Kamedis PSO Medis Body Cream is a safe and effective treatment for the relief of psoriatic symptoms, especially for mild-to-moderate cases of psoriasis. By providing a mechanical barrier, this treatment maintains a moist skin environment, protects the skin from additional irritation and facilitates the healing process. The addition of herbal extracts known also for their strong anti-inflammatory3- 5 and anti-proliferative6 activities contribute to the healing process of psoriatic lesions.

• Reduction of at least 50 percent in pruritus was reported by 10 out of 11 patients (92 percent).

• No worsening or any adverse events were observed.

• No additional treatment was needed.

• 85 percent of subjects were satisfied with the treatment.

Results See figures 1-3.

Conclusions 

Treatment with PSO Medis Body Cream was safe and well tolerated in patients with stable plaque psoriasis.

Treatment with PSO Medis Body Cream demonstrated clear evidence of efficacy in reducing symptoms of plaque psoriasis, especially in mild-to-moderate cases of psoriasis.Treatment with PSO Medis Body Cream maintains a moist skin environment, protects the skin from additional irritation and facilitates the healing process.

About Kamedis 

Kamedis, a research-based pharmaceutical/ dermaceutical company, specializes in dermatology with a vision to leverage efficacious herbal formulations with pharmaceutical standards. Kamedis’ skin care products are based on unique combinations of herbal extracts, backed by clinical trials and case reports. Kamedis products are safe for long term use and are steroid, paraben and sodium lauryl sulfate-free 

PSO Medis Body Cream is an effective and complementary skin care to the inside-out treatment plan that you create for your patients. It is clinically proven to be effective and safe, providing long-term relief.

Kamedis products are available at Emerson Ecologics & Natural Partners www.emersonecologics. com/searchhighlight.aspx?keywords= kamedis or www.kamedis-usa.com. 

For a full list of references, visit www.naturalpractionermag.com

Kyowa Hakko USA

600 Third Ave., 19th Fl.
New York, NY 10016
Phone: (800) 596-9252 • Fax: (212) 421-1283
Email: info@kyowa-usa.com
Websites: www.kyowa-usa.com; www.setriaglutathione.com

The Benefits of Glutathione

Glutathione (GSH) is provided both through the diet and through endogenous synthesis. The best food sources are fresh fruits and vegetables and freshly prepared meats.1 Most methods of food processing destroy GSH.

Modern diets are often devoid of GSH due to the excessive intake of processed foods. Dietary intakes of GSH among Americans have been measured in at least two studies. In the first, intakes ranged from a low of 3 mg per day to a high of about 150 mg per day, with a mean intake of 35 mg per day.1 Another study found an even wider range of intakes among men—from 5 mg to 242 mg per day and 7 to 96 mg per day in women, with most people regardless of gender falling below 60 mg per day.18 If the best diets provide close to 250 mg per day and the mean intake is only 35 mg, there is a considerable gap in much of the population.Thus, supplemental intake of 150-250 mg per day would be likely to ensure an adequate intake for most people.

Because of endogenous synthesis, GSH has not been considered an essential nutrient and no recommended intake level has been established. Moreover, the variable levels of glutathione in different tissues and organs present a challenge both to measuring status and estimating needs. Early studies did not find an appreciable increase in plasma levels after supplementation, and thus it was thought that oral GSH was not bioavailable. However, over the past 20 years, numerous studies have demonstrated that plasma levels are not indicative of levels in other tissues and that oral GSH is bioavailable.3-9 Animal evidence suggests that it may be delivered preferentially to specific sites of high demand such as the lungs and intestines.3 

GSH is present in all tissues and body fluids, both inside and outside of cells. The entire body pool is made and degraded daily through a continuous turnover of both cellular and extracellular GSH.

Potential benefits of oral supplementation 

A randomized, double-blind, placebo-controlled study of 54 healthy adults revealed that glutathione levels of those taking 1,000 mg of Setria® Glutathione a day for six months increased 30 to 35 percent in many compartments including red blood cells, lymphocytes and plasma, and of those taking 250 mg of Setria Glutathione increased in whole blood. And as GSH stores increased in the high-dose group, so did the function of natural killer (NK) cells, a marker for increased immune defense. These findings are consistent with previous pre-clinical studies and indicate that long-term oral administration GSH is an effective means of enhancing body stores of GSH.21 

GSH supplementation may help increase levels of GSH in certain circumstances associated with low glutathione status including cigarette smoking22, heavy drinking23, use of large numbers of prescription and non-prescription medications2 and chemotherapy.2 

GSH levels fluctuate diurnally with lowest levels found in the morning, which may present a window of vulnerability that could be addressed through increased oral intake.The morning shortfall becomes even lower with advancing age.

References: 

1 Jones DP et al. Nutr Cancer. 1992;17:57-75.

2 Jones DP. Natural Medicine Journal 3(2), February 2011.

3 Aw TY, Williams MW. Am J Physiol. 1992;263(5 Pt1) :G665-72.

4 Kariya C et al. Am J Physiol Lung Cell Mol Physiol. 2007;292:L1590-97.

5 Hagen TM et al. Am J Physiol. 1990;259;G524-29.

6 Iantomasi T et al. Biochim Biophys Acta.1997;1330:274-83.

7 Aw et al. Chem Biol Interact. 1991;80:89-97.

8 Hunjan MK, Evered DF. Biochim Biophys Acta 1985;815:184-88.

9 Vina et al. Br J Nutr. 1989;62:683-91.

10 He M et al. J Nutr. 2004;134:1114-19.

11 Favilli F et al. Br J Nutr. 1997;78(2):293-300.

12 Lang CA et al. J Lab Clin Med.1992;120(5):720-25.

13 Van Lieshout EM, Peters WH. Carcinogenesis.1998 Oct;19(10):1873-5.

14 Lang CA et al. J Lab Clin Med.2002;140(6):380-81.

15 Julius M et al, J Clin Epidemiol.1994;47(9):1021-26. 

16 Ashfaq S et al. J Am Coll Cardiol. 2006 Mar 7;47(5):1005-11.

17 Richie JP et al. Nutr Cancer. 2008;60(4):474-82.

18 Flagg EW et al. Am J Epidemiol.1994;139(5):453-65.

19 Cohen SM et al. Br J Ophthalmol. 1994 Oct;78(10):791-94.

20 Coral K et al. Eye. 2006 Feb;20(2):203-7.

21 Richie, P. et al. Enhanced Glutathione Levels in Blood and Buccal Cells by Oral Glutathione Supplementation. Experimental Biology. April 22,2013. 

22 Moriarty SE et al. Free Radic Biol Med.2003;35(12):1582-88.

23 Joshi PC et al. Am J Physiol Lung Cell Mol Physiol. 2007;292(4):L813-23.

24 Blanco RA et al. Am J Clin Nutr. 2007 Oct;86(4):1016-23.

25 Centers for Disease Control and Prevention.Www.cdc.gov/nhcs/data/hus/hus07.pdf 

26 Natural Medicines Comprehensive Database.Www.naturaldatabase.com 12.18.2008. 

27 Witschi A et al. Eur J Clin Pharmacol.1992;43(6):667-69.

Nutritional Magnesium Association

289 N. Cleveland St.
Orange, CA 92866
Phone: (714) 605-1100
Email: info@nutritionalmagnesium.org
Website: www.nutritionalmagnesium.org

Do Your Patients Get Enough Magnesium to Protect Against Depression and Stress?

Jeffrey Janata, PhD, of University Hospitals Case Medical Center (Cleveland, OH) stated, “The more common connection between stress and depression now is in the accumulated stresses that come in a world in which we have multiple roles, or we’re juggling multiple stressors or we are confronted with various major changes in our lives that overwhelm our bodies’ ability to respond to each of them and produce stress hormones at such a level that it begins to affect us physically and emotionally.” 

Stress can be physical or emotional, and according to Mildred S. Seelig, MD, MPH, “Stress hormones cause a sudden rise in magnesiumdependent reactions.Energy production, nerve-impulse transmission, increased muscle function and responses of heart and blood vessels all require magnesium. Our need for magnesium soars as we respond to stress. Thus, our reactions to acute stress really put our magnesium status to the test.” 

A March 2013 study has found magnesium supplementation to be a viable, natural, non-toxic solution to depression, which avoids the side-effects of antidepressants.1 The results of the study demonstrated that the lower the magnesium intake, the more symptoms of depression were recorded. These symptoms persisted even after adjustments for sex, age, body mass index, smoking (current and former), education, physical activity and marital status.

A January 2012 study in Neuropharmacology found that magnesium deficiency induces anxiety.2 

How magnesium deficiency can induce anxiety and cause depression is explained further by Carolyn Dean, MD, ND, Medical Advisory Board member of the Nutritional Magnesium Association. “A deficiency of magnesium magnifies anxiety, depression and stress. Serotonin, the feel-good brain chemical that is boosted artificially by some medications, depends on magnesium for its production and function. A person who is going through a stressful period without sufficient magnesium can set up a deficit that, if not corrected, can linger, causing anxiety, depression and further health problems.” 

“During stress, magnesium is mobilized from available stores that are not life-maintaining—for example, as part of bone-surface minerals. The mobilized magnesium enters the blood, which carries it to the heart, where it helps provide the energy needed by the heart to pump more rapidly and strongly,” added Andrea Rosanoff, PhD, of the Center for Magnesium Education & Research. It also supplies the increased magnesium our voluntary muscles require, for a short time, during times of stress. However, these temporarily elevated blood magnesium levels signal the kidneys that there is too much magnesium in the body. In response, they decrease reabsorption of the magnesium from the blood as it circulates through the kidneys, with the result that more magnesium is eliminated in the urine and less is restored to the circulating blood. This reduces the amount of magnesium in the entire body. If magnesium nutrition has been adequate, the body’s magnesium stores are sufficient to meet this sudden, usually short-lived, increased need.But if the body’s magnesium stores are too low, and the stress persists, the stress hormones begin to mobilize magnesium from even vital tissues, such as the heart, and the response to acute stress can become dangerous.

“With prolonged stress-inducing conditions, the need for magnesium remains abnormally high during the body’s response to the sustained stress. Suboptimal magnesium stores can be exhausted. Even with seemingly adequate magnesium nutrition, there can be decreased resistance to chronic stress.” 

Because magnesium deficiency can be an underlying cause of anxiety and depression,1-3 make sure your patients are not magnesium deficient. Magnesium in the blood does not correlate with the amount of magnesium in other parts of the body. In fact, if you are under stress, your body pumps magnesium out of the cells and into the blood, giving the mistaken appearance of normality on testing in spite of body-wide depletion.

Unfortunately, most magnesium evaluations done in hospitals and in laboratories use the antiquated serum magnesium test. A magnesium RBC (red blood cell) test will give a more accurate result.

A free 32-page guide to the benefits of magnesium, written by Dr. Dean, is available as a free download at www.nutritionalmagnesium.org. 

References: 

1 Yary T, Aazami S, Soleimannejad K. 2013.“Dietary intake of magnesium may modulate depression.” Biol Trace Elem Res 151(3): 324–29.Www.ncbi.nlm.nih.gov/pubmed/23238611. 

2 Sartori SB, Whittle N, Hetzenauer A, Singewald N.2012. “Magnesium deficiency induces anxiety and HPA axis dysregulation: modulation by therapeutic drug treatment.” Neuropharmacology 62(1): 304–12.Www.ncbi.nlm.nih.gov/pubmed. 

3 Eby GA, Eby KL. 2006. “Rapid recovery from major depression using magnesium treatment.” Med Hypotheses 67(2): 362-70.Www.ncbi.nlm.nih.gov/pubmed/16542786?ordinalpos= 6&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed _ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_R VdocSum.

Protocol for Life Balance

244 Knollwood Dr.
Bloomingdale, IL 60108
Phone: (877) 776-8610 • Fax: (855) 833-9012
Email: info@protocolforlife.com
Website: www.protocolforlife.com

Resolving Vitamin B12 Deficiency Using Oral Supplementation with NOW Foods Methyl B-12 5,000 mcg Lozenges

By L.G. Ber, MD and R.L. Sharpee, PhD

Role of Vitamin B12 in the Body 

Vitamin B12 (aka cobalamin) is an essential nutrient that can only be obtained from diet or supplements. Cobalamin plays a critical role in DNA synthesis and neurological function. Cobalamin deficiency can lead to a wide spectrum of blood related and neurologic symptoms (e.g., depression, memory loss, peripheral neuropathy) that can be reversed by early diagnosis and treatment.

The true prevalence of vitamin B12 deficiency is unknown; however, the incidence appears to increase with age, with an estimated 15 percent of people over 65 having low serum cobalamin.1 Because the normal body stores of cobalamin are significant (2,000 to 5,000 mcg, mostly in the liver), it can takes years to develop symptoms of deficiency.The signs are often non-specific and hard to recognize. Although levels of <200 pg/ml have long been used to diagnose B12 deficiency, the suboptimal range has recently been adjusted downward, to between 200 and 350 pg/ml.2 

Because cobalamin absorption requires intact production of intrinsic factor (IF) in the stomach, the elderly are more likely to develop deficiency. Gastric juices enable extraction of cobalamin from food and IF binds with extracted cobalamin for further absorption in the small intestine. Eventually, body reserves of cobalamin are depleted and symptoms of deficiency emerge. Because dietary vitamin B12 is found almost exclusively in food of animal origin (primarily meat), vegetarians have a significant risk of becoming cobalamin-depleted.

Vitamin B12 Deficiency is Diagnosed.What’s Next?

When vitamin B12 deficiency is present, identifying the underlying cause is important.However, independent of the mechanism leading to B12 deficiency, correction of cobalamin shortage is required.

Traditionally, physicians have administered vitamin B12 injections to bypass the digestive tract, as cobalamin absorption is assumed to be compromised. While this can be one of the causes for vitamin B12 deficiency, current clinical research conducted with high-dose oral vitamin B12 supplementation challenges the traditional practice of injections.

Since the discovery of its critical role in cobalamin absorption, the IF-dependent pathway has been understood to be the sole mechanism by which vitamin B12 can cross the gastrointestinal (GI) cell membrane.However, IF allows for absorption of only up to 3 mcg of vitamin B12 from a single meal or supplementation.3 Since the typical multivitamin contains only about 6 mcg and absorption from this low dose has to rely on intact IF production, oral supplementation with a typical multivitamin is not an effective way to address vitamin B12 deficiency. In contrast, a single injection can deliver 1,000 mcg of vitamin B12, which is administered once a week at first, followed by a once a month regimen for the rest of the patient’s life.

Fortunately, another mechanism is operative for treating vitamin B12 deficiency.Research has shown that vitamin B12 can be absorbed by “passive diffusion” without IF participation when administered in high doses.3 Although only about one percent of orally administered cobalamin is absorbed in the GI tract by this mechanism, the amount absorbed becomes significant as the dose of vitamin B12 increases. Recent human bioavailability studies with 10,000 mcg vitamin B12 support this conclusion (Unpublished, NOW Foods, Bloomingdale, IL; 2011-2012).

Injections or Supplementation?

Clinical confirmation of the effectiveness of oral vitamin B12 in the form of methylcobalamin lozenges, comes from a study conducted at ABC Wellness Clinic (Sterling Heights,MI) in collaboration with NOW Foods®.4 In this clinical trial, 10 patients with newly diagnosed cobalamin deficiency were randomly assigned to receive either once a week B12 injections or daily high-dose 10,000 mcg methylcobalamin lozenge (NOW®, Methyl B- 12, 5,000 mcg) for eight weeks. The study demonstrated that vitamin B12 lozenges were as effective as injections (Figure 1). All patients’ cobalamin and homocysteine levels returned to normal and their symptoms improved independent of the treatment group to which they belonged.

Additionally, lozenge supplementation offered a significant cost advantage as compared to injections. In this study, the cost of supplementation was approximately $35 for eight weeks. The cost of just one office visit and a single injection was estimated to be $100, adding up to $800 for the duration of the study.

To summarize, confirmed efficacy, validated mechanism of absorption, an excellent safety record, ease of administration, and clear economic advantage makes oral highdose vitamin B12 a viable option in addressing cobalamin deficiency.

References: 

1 Clarke R, Grimley Evans J, Schneede J, et al. Age and ageing. Jan 2004;33(1):34-41.

2 Spence JD, Stampfer MJ. JAMA. Dec 21 2011;306(23):2610-2611.

3 Andres E, Dali-Youcef N, Vogel T, Serraj K, ZimmerJ. Int J Lab Hematol. Feb 2008;31(1):1-8.

4 Culik DA BL, Sharpee RL, Pacholok SM. AANP 2012 Conference: ABC Wellness; NOW Foods;2012.

Quincy Bioscience

301 S. Westfield, Ste. 200
Madison, WI 53717
Phone: (888) 895-MIND (6463) • Fax: (608) 237-2164
Email: tolson@quincybioscience.com
Website: www.prevagenpro.com

Prevagen Professional Shown to be Safe and Improve Memory

Every seven seconds in the United States, another Baby Boomer turns 65. Not surprisingly, as Baby Boomers have gotten older, they are increasingly concerned with healthy aging and minimizing the cognitive changes and memory lapses that are often thought of as normal aging.

The ability to remember is central to many people’s quality of life. For many Baby Boomers, a deterioration of cognitive function is the greatest concern in aging.According to the Natural Marketing Institute’s “Healthy Aging Survey,” the ability to remember was even more important than other common aging challenges.1 

In normal aging, mild memory problems occur as a result of excessive intracellular calcium caused by poorly supported calcium- binding proteins. These naturally occurring proteins support brain function, but are diminished as we age. Supplementing these proteins has shown to support brain cell function in laboratory studies and to improve memory in human clinical trials.

Apoaequorin is a calcium-binding protein that supplements our own proteins.Originally discovered in jellyfish, apoaequorin is the main ingredient in the memory supplement Prevagen Professional.* 

Because Baby Boomers are not content to accept cognitive decline as normal, they are being proactive and looking for alternatives to accepting mild memory loss associated with aging. Many are turning to apoaequorin, a safe and effective brain health supplement.* 

Safety of Prevagen 

Apoaequorin was originally obtained from the luminescent jellyfish species Aequorea victoria, and is now produced in a fermentation process at cGMP- (current good manufacturing practice) and NSF-certified facilities.

The safety of apoaequorin is well-established based on the results of both acute and sub-chronic toxicology investigations.

The sub-chronic toxicity study in rats recently published found that at 1,000 times the equivalent human dosing level of Prevagen Professional, there were no observed adverse effects attributable to the administration of apoaequorin in clinical or ophthalmological signs, body weight, body weight gain, food consumption, food efficiency, clinical pathology or histopathological changes.2 

A second safety study looking at the allergenicity of apoaequorin found that the protein is not a known allergen and is also not likely to cross-react with other known allergens.3 Based on critical evaluation and the acceptance of a qualified, independent scientific panel, apoaequorin is now self-affirmed GRAS (generally recognized as safe) and can be utilized as a food ingredient.

Does Prevagen Work?

The effect of apoaequorin on cognitive function was studied in a large doubleblind, placebo-controlled trial. Two hundred and eighteen adult participants over the age of 40 who reported mild memory concerns, but were not diagnosed with any disease or disability, were randomly assigned to two test groups—the control group (placebo) and the experimental group (apoaequorin 10 mg oral).

All participants were assessed over a 90- day period using a computer-based cognitive testing protocol. Additionally, participants completed a self-assessment tool, the AD8, to report on measures of quality of life and activities of daily living.4 

Prevagen Research Findings 

Overall, participants in the experimental group (apoaequorin 10 mg) saw a significant change over the 90-day study period in the following areas:

• Attention*

• Visual learning*

• Verbal learning*

• Memory*

• Delayed recall*

• Executive function* 

Additionally, participants scoring 0-1 (minimal cognitive difficulty) on the AD8 screening test experienced a robust reduction in total errors of 29 percent compared to baseline.

The data suggest apoaequorin is a safe and potentially effective approach to help those who experience mild memory problems in aging.* Apoaequorin has also been tested and found effective in two canine trials.

Presently, apoaequorin is only available in the dietary supplement brand Prevagen.Prevagen and Prevagen Chewables contain 10 mg of apoaequorin. Prevagen Extra Strength contains 20 mg, and Prevagen Professional has 40 mg of apoaequorin per capsule. Prevagen Professional is exclusive to the healthcare practitioner channel. In addition to supplementation, brain exercise games can be found at Prevagengames.com.

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

References: 

1 Natural Marketing Institute, “Healthy Aging Survey”, 2008.

2 Moran, D. et al, “Safety assessment of Apoaequorin, a protein preparation: Subchronic toxicity study in rats.” Food & Chemical Toxicology. 2013 March.

3 Goodman, R.E. (2010). Bioinformatic Analysis of Apoaequorin to Assess Potential Allergenic Cross- Reactivity. Food Allergy Research and Resource Program, Food Science and Technology, University of Nebraska. Final Report submitted to Quincy Bioscience.

4 Underwood, M.Y., Sivesind, P.A., Gabourie, T.A., Lerner, K.C. The effects of the calcium-binding protein apoaequorin on memory and cognitive functioning in older adults. Study presented at the Association international Conference, July 20, 2011, Paris, France.

Xlear Inc.

P.O. Box 1421
American Fork, UT 84003
Phone: (877) 599-5327 • Fax: (801) 492-8011
Email: sales@xlear.com
Website: www.xlear.com

Natural Sinus Care

By Ryan Hogan, Communications Director

Upper respiratory infection (URI) is a term used to describe acute infections involving the nose, paranasal sinuses, pharynx, larynx, trachea, Eustachian tubes, and bronchi. The National Center for Health Statistics (NCHS) estimates that, in 1996, 62 million cases of the common cold in the United States required medical attention or resulted in restricted activity. The onset of these non–influenza-related URIs account for an estimated economic impact of $40 billion annually.4 Most URIs occur more frequently during the cold winter months, because of close proximity to one another.Adults develop an average of three colds annually and experience a wide spectrum of symptoms ranging from headache, facial tenderness, sneezing, pressure or pain, discolored nasal drainage, nasal congestion, sore throat, cough and fever.

Sinus Problems 

In the U.S., allergic rhinitis contributes to approximately two million missed school days and 100 million missed work days annually.5 The most common sinus problems are allergies, the common cold, sinus headaches, sinusitis, nasal polyps and middle ear infections.These URIs are the reason Americans spend more than $1 billion each year on OTC (over-the-counter) medications and $150 million on prescriptions to treat them.6 

Natural Alternatives 

Keeping the nose clean is important because essentially all respiratory problems have their beginning there.7While their normal treatment is antibiotics; the research on xylitol suggests a new solution for prevention and treatment without the concern about antibiotic resistance and the overuse or inappropriate usage of prescription medications. The unique five carbon structure of xylitol is stable and will not link to other sugars. The result of this is that bacteria can consume xylitol; however, they’re unable to digest it.This means that harmful substances are not produced and the bacteria themselves do not reproduce in a xylitol-rich environment.8 Although xylitol was originally approved in 1963 by the U.S. Food and Drug Administration (FDA), the groundbreaking Turku Sugar Studies conducted in the 1970s is what brought xylitol to the forefront.

Further research led to the discovery that xylitol prevented bacteria from sticking to the cells in the nose.9 The University of Iowa later found that xylitol osmotically pulls fluid into the airway. This moisturizes the airway surface liquid (ASL) and allows the cilia in the nasal airway to move more freely.10 The effect of a xylitol nasal spray was a six times reduction in nasal coagulase-negative staphylococcus.10 Based on in-vivo and in-vitro clinical research, Dr. Jones created a highly effective nasal spray under the brand name Xlear to reduce nasal bacteria, wash away airborne pollutants, and decrease membrane size making breathing easier.

Prevention 

The World Health Organization (WHO) estimates that more than 1.6 million people die every year from pneumococcal infections.The primary causes of death are: pneumonia, meningitis and sepsis.11 The major pathogen and culprit involved in those conditions is in the nose, Streptococcus pneumoniae. Regular use of a xylitol nasal spray supports sinus health and helps maintain healthy nasal tissues.

Today’s world has an increasingly common goal of a healthy lifestyle. The research conducted over the past four decades has revealed that xylitol, particularly in a nasal spray such as Xlear Nasal Spray, can significantly benefit upper respiratory health as a safe and proven solution since it supports and optimizes the body’s natural defense against growing sinus problems.

References: 

1 Wessels MR. Clinical practice: streptococcal pharyngitis. N Engl J Med 2011; 364:648–655.

2 Tero Kontiokari, M. U., et al (1998). Antiadhesive effects of xylitol on otopathogenic bacteria. Anti Microb Chemother, 563-565.

3 Wenzel RP, Fowler AA III. Clinical practice: acute bronchitis. N Engl J Med 2006; 355:2125–2130.

4 Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med 2003; 163:487–494.

5 Mark D. Scarupa, et al. 2005.

6 American Academy of Allergy, Asthma and Immunology, 2014.

7 Jones, A. (2010) No more allergies. (2):30 

8 Reusens, B. (2004). Remacle, Claude; Reusens, Brigitte, ed. Functional foods, ageing and degenerative disease. Cambridge, England: Woodhead Publishing. P. 202. ISBN 978-1-85573-725-9.Retrieved March 14, 2012.

9 Uhari M., Kontiokari T, et al: Effect of Xylitol on Growth of Streptococcus Pneumoniae in the Presence of Fructose and Sorbitol. Antimicrob Agents Chemother. Jan 2001; 45(1): 166–169. Dept of Pediatrics.

10 Zabner J., *. M. (October 10, 2000). The osmolyte xylitol reduces the salt concentration of airway surface liquid and may enhance bacterial killing.Proc Natl Acad Sci U.S.A. , 97(21): 11614–11619.

11 World Health Organization. Pneumococcal vaccines.The Weekly Epidemiological Record. 2003; 14:110-9.