January 2011

The Professional Educator

7-Keto (three-acetyl-7-oxo-dehydroepiandrosterone) for Maintaining Healthy Body Composition†

Peter Bongiorno ND, LAc

Despite an increased awareness in health and ostensible strides in medical technology, about 64% of American adults are currently classified as overweight and 25 to 30% are clinically obese.1,2 Due in large part to this obesity epidemic, life expectancy has decreased for the first time in two centuries.3 It is estimated

that the life-shortening effect of obesity will rise from its current level of about four months, to up to five years or more in the coming decades as the young obese bring their elevated risk of death into middle and older ages. Additionally, the health and life expectancy of minority populations may be hit hardest due to increases in childhood obesity and limited health care access.4

While almost three-fourths of Americans are attempting to lose or maintain body weight, research suggests that most of these efforts will not be successful.5 Some emerging evidence supports the hypothesis that individuals who have a low-metabolism may be predisposed to weight gain and obesity as a result of low-energy output caused by a low resting metabolic rate (RMR), a lack of physical activity, or both.6,7 To make this more challenging, recommending lower caloric intake can slow body metabolism even further. As RMR represents 60% of total energy expenditure, compared to 30% as non-resting energy expenditure and 10% as heat 8, small increases in RMR may result in considerable energy consumption over time and may aid in weight loss.

7-Keto May Help Support Healthy RMR† Supplementation that could help with this issue of RMR while lowering dietary caloric intake would be a clear advantage to both the individual with weight concerns and the health care practitioner who has limited options. Three-acetyl-7-oxo-dehydroepiandrosterone (7-Keto), is a naturally occurring metabolite (breakdown product) of the hormone dehydroepiandrosterone (DHEA). It is believed to support normal breakdown of lipids in the body and may prove helpful in this by maintaining metabolic rate within the normal range†. Case reports have also suggested positive benefits in maintaining mood.9†

Animal studies have shown that 7-Keto is more potent than DHEA in supporting the function of thermogenic enzymes glycerol-3-phosphate dehydrogenase and malic enzyme.10 7-Keto has also been shown to support the rate of mitochondrial substrate oxidation, as well as liver catalase activity and fatty acetyl-CoA oxidase activity.11

Two placebo-controlled studies in healthy overweight adults demonstrated significantly greater weight loss in subjects using 100 mg of 7-Keto twice daily than in those using placebo over 8 weeks. It is important to note that in both studies the supplementation was used in conjunction with a calorie-restricted diet and exercise program.12,13 In one of these studies, there was an observed increase in triiodothyronine (T3) hormone with no change in levels of thyroid stimulating hormone (TSH) or thyroxine (T4). Since

T3 is considered a more potent active form of thyroid hormone, it is considered favorable for maintaining optimal metabolism and supporting healthy body weight.

A more recent 2007 randomized, double-blind, placebo-controlled, crossover trial of overweight adults on a calorie-restricted diet studied 7-Keto both as a single supplement (50 mg BID), and also in a combination product called HUM5007, which included 250 mg calcium citrate, 150 mg green tea extract (standardized for 50% epigallocatechin gallate), 50 mg 7-Keto, 50 mg ascorbic acid, 0.1 mg chromium nicotinate and 0.0025 mg cholecalciferol (also BID). This study evaluated 30 women and 10 men (mean age of 38.5 years) and found that during placebo treatment, those who were on the calorie-restricted diet alone had a 3.9% decrease in RMR. Compared to placebo however, RMR increased significantly by 1.4% and 3.4% during the 7-Keto and HUM5007 treatment periods respectively. The authors suggested that 7-Keto appeared to support healthy resting energy expenditure in these individuals and that in conjunction with a calorie-restricted diet and exercise, 7-Keto may safely help to maintain RMR while dieting, and may be a benefit to individuals concerned with supporting their energy expenditure.14

Dosage and Safety Although a larger body of research is needed, so far 7-Keto seems to have a reasonable safety profile using 50 mg twice a day. The theoretical concern is that using 7-Keto can cause increased levels of androgens, DHEA and estrogens in the body. Rat studies suggest 7-Keto does not activate the androgen receptor15 or convert to other androgens or estrogens.16,17 Rat single oral dosing of 2000 mg/kg demonstrated no adverse effects.18 In monkeys, doses of 250, 500, and 1000 mg/kg were given up to 11 days. Animals at the highest doses did experience vomiting. Post mortem studies on these animals showed no abnormalities.19

Tolerance in humans to 7-Keto seems to be quite good. In one study of 40 volunteers, 7-Keto at the dose of 50 mg twice a day was generally well tolerated, with minimal adverse events, which were self-limiting and none resulted in discontinuation from the trial. These events included diarrhea, flatulence, palpitations, and upper respiratory infection.14 Another safety study in humans has shown that 7-Keto did not raise estrogen or testosterone levels or produce any other negative effects at levels up to 200 mg per day for eight weeks. In this study, a safety and pharmacokinetic study in human males at 50, 100, and 200 mg/day showed that 7-oxo-DHEA was converted to 7-oxo-DHEA-S which had a minimal half-life of 2.17 hours and did not accumulate.20

The long-term safety of 7-Keto for humans has not been demonstrated, and, because it is chemically related to steroid hormones, the potential for adverse effects should be carefully considered by the clinician. Additionally, the increase in T3 levels resulting from taking 7-Keto could, in theory, produce adverse effects on the heart or promote bone loss. For these reasons, people wishing to take 7-Keto, particularly those who have a thyroid or cardiovascular disorder or are taking thyroid hormone should consult a physician.

In conclusion, research regarding the use of 7-Keto is compelling, but relatively sparse. The available literature does suggest a benefit using caloric restriction with 7-Keto to aid in supporting basal metabolic rate in individuals with weight concern. There may also be an advantage in using 7-Keto to help maintain healthy T3 levels. Caution is recommended in those patients who may be hyperthyroid, and it may be advisable to monitor for symptoms such as acne and facial hair as well as check endocrine hormone levels as a precaution when using 7-Keto. It is always recommended the clinician first address diet, exercise, sleep, and stress factors to optimize healthful weight loss.

Bio: Peter Bongiorno ND, LAc trained in naturopathic medicine and acupuncture at Bastyr University. Previously, he was a pre-doctoral fellow at the National Institutes of Health and Yale University, in the field of clinical neuro-endocrinology. Peter is co-director of InnerSource Health in New York City and Long Island, and is VP of the New York Association of Naturopathic Physicians. He is a major contributor to the third edition of the Textbook of Natural Medicine and has recently authored the textbook Natural and Conventional Therapies for Depression. More information about Dr. Bongiorno: www.InnerSourceHealth.com/depression.

References:1. Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999–2000. JAMA 2002; 288:1723–1727.2. US Department of Health and Human Services. Healthy People 2010 (conference ed, in 2 vols). Washington DC: US Department of Health and Human Services; 2000.3. Olshansky SJ, Passaro DJ, Hershow RC, Layden J, Carnes BA, Brody J, Hayflick L, Butler RN, Allison DB, Ludwig DS.A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005;352(11):1138-45.4. Strauss RS, Pollack HA. Epidemic increase in childhood overweight, 1986-1998. JAMA 2001;286:2845-2848.5. Mokdad AH, Bowman BA, Ford ES, Vinicor F, Koplan JP. The continuing epidemics of obesity and diabetes in the United States, JAMA 2001; 286:1195–1200.6. Astrup A. Macronutrient balances and obesity: the role of diet and physical activity, Public Health Nutr 1999; 2: 341–347.7. Astrup A, Thermogenic drugs as a strategy for treatment of obesity, Endocrine 2000; 13: 207–212.8. Leibel RL, Rosenbaum M, Hirsch J. Changes in energy expenditure resulting from altered body weight, N Engl J Med 1995; 332: 621–628.9. Sageman S, Brown RP. 3-acetyl-7-oxo-dehydroepiandrosterone for healing treatment-resistant posttraumatic stress disorder in women: 5 case reports. J Clin Psychiatry. 2006; 67(3):493-610 Lardy H, Partridge B, Kneer N, Wei Y. Ergosteroids: induction of thermogenic enzymes in liver of rats treated with steroids derived from dehydroepiandrosterone, Proc Natl Acad Sci U S A 1995; 9: 6617–6619.11. Bobyleva V , Bellei M, Kneer N, Lardy H. The effects of the ergosteroid 7-oxo-dehydroepiandrosterone on mitochondrial membrane potential: possible relationship to thermogenesis, Arch Biochem Biophys 1997; 341:122–128.12. Kalman DS, Colker CM, M.A. Swain, G.C. Torina and Q. Shi, A randomized, double blind, placebo controlled study of 3-acetyl-7-oxo-dehydroepiandrosterone in healthy overweight adults, Curr Ther Res 2000; 61: 35–442.13. Zenk JL, Helmer TR, Kassen LJ, Kuskowski MA. The effect of 7-Keto Naturalean on weight loss: a randomized, double-blind, placebo-controlled trial, Curr Ther Res 2002; 63: 263–272.14. Zenk JL, Frestedt JL, Kuskowski MA. 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(9):629-34. 15. Miyamot H , Yeh S, Lardy H, Messing E, Chang C. Delta-5-androstenediol is a natural hormone with androgenic activity in human prostate cancer cells, Proc Natl Acad Sci U S A 1998; 95: 11083–11088.16. Davidson M, Marwah A, Sawchuk RJ, Maki K, Marwah P, Weeks C, et al., Safety and pharmacokinetic study with escalating doses of 3-acetyl-7-oxo-dehydroepiandrosterone in healthy male volunteers, Clin Invest Med 2000; 23: 300–310.17. Lardy H, Kneer N, Wei Y, Partridge B, Marwah P. Ergosteroids II: biologically active metabolites and synthetic derivatives of dehydroepiandrosterone, Steroids 1998; 63: 158–16518. Lardy H Henwood SM, Weeks CE. An acute oral gavage study of 3-ß-acetoxyandrost-5-ene-7,17-dione (7-oxo-DHEA-acetate) in rats Biochem. Biophys.Res.Commun. 1999: 254 (1): 120-123.19. Henwood SM, Weeks CE, Lardy H. An escalating dose oral gavage study of 3beta-acetoxyandrost-5-ene-7, 17-dione (7-oxo-DHEA-acetate) in rhesus monkeys. Biochem.. Biophys. Res. Commun. 1999: 254 (1): 124-126.20.Davidson MH, Weeks CE, Lardy H, et al. Saftey and endocrine effects of 3-acetyl-7-oxo DHEA (7-keto DHEA). FASEB J 1998;12:A4429.

†These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure or prevent any disease.

*These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure or prevent any disease.

Hawthorn Extract 600 mg60 Vcaps®

Vitamin B12 has the largest and most complex chemical structure of all vitamins. Most of its functions are related to its co-enzyme activity, such as enzymes needed for the production of DNA during cell division.* It is required for the synthesis of the amino acid methionine, which helps to maintain already healthy serum homocysteine levels.* B12 is also necessary for the maintenance of a healthy nervous system.*

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Glycine is a non-essential amino acid and has the simplest structure of all amino acids, allowing it to fit easily within protein chains and make space for structurally larger amino acids. This feature makes it very important for specific bodily functions. Glycine is also a precursor of creatine, which is used to construct DNA and RNA.* And it supports glycogen storage, thereby making more glucose available for energy production.* The amino acid Glycine is non-chiral and only has one form without a D- or L- designation.

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The Professional EducatorJanuary 2011

7-Keto-DHEA is a natural metabolite of DHEA, and like DHEA, its level in the body is known to decline with age. Furthermore, a decrease in metabolic rate often accompanies the decreased production of DHEA and its metabolites. However, unlike DHEA, 7-Keto-DHEA does not convert to estrogen or testosterone. 7-KETO® is the patented ingredient that has been shown in clinical studies to assist in the maintenance of a healthy body weight and maximize results of a proper diet and exercise.* The special blend of ingredients in Protocol for Life Balance™ 7-KETO® LeanGels™, including CLA and green tea polyphenols, work synergistically to provide healthy weight management, as well as antioxidant power.*

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*These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure or prevent any disease.

Echinacea Liquid Extract 4 oz.

Curcumin, the active component in Turmeric, has been demonstrated to support joint mobility and flexibility, as well as support a balanced immune and inflammatory response due to its effects on the COX-2 enzyme and antioxidant potential.* However, in spite of all of these advantages, due to its hydrophobic quality, most forms of Curcumin lack bioavailability. Curcumin Phytosome contains a patented ingredient, providing Curcumin complexed with Phosphatidylcholine that clinically demonstrates increased absorption and bioavailability, delivering more of the benefits of this bioactive compound as compared to standard Curcumin extracts.*

Echinacea is an herb widely known for its immune-supporting properties.* Studies indicate that Echinacea constituents, including alkylamides and caffeic acid derivatives, can affect both adaptive and innate immune responses, which may help to support a healthy immune system.*

Chlorophyll 100 mg90 Caps

Chlorophyll is the pigment that plants use to trap light needed for photosynthesis; it is what gives plants and algae their green color. Chlorophyll has potent antioxidant properties and some reports indicate that Chlorophyll supplements can act as an internal deodorant.* Scientific studies show that chlorophyll may help to support healthy cellular reproduction cycles and liver function, and can help to encourage proper detoxification mechanisms.* Alfalfa is included in this product as an additional source of chlorophyll, as well as a rich source of vitamin K.

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January 2011

*These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure or prevent any disease.

Chlorella 400 mg 100 Vcaps®

St. John’s Wort (Hypericum perforatum) has a long history of traditional use as an overall health tonic. However, more recent scientific research has provided evidence for its ability to promote healthy serotonin and monoamine (dopamine and norepinephrine) metabolism as well as GABA receptor function.* This St. John’s Wort Extract is standardized to 0.3% hypericin while retaining all the whole-plant synergistic benefits.

Chlorella vulgaris, a single-celled fresh water plant, is a storehouse of enzymes, vitamins, minerals, and phytonutrients. In addition, it contains high amounts of purifying chlorophyll, as well as the nucleotides RNA/DNA. Because Chlorella contains numerous nutrients, including antioxidants, it is thought to exert its antioxidative properties by scavenging free radicals created by various environmental factors.* This product is carefully produced using Chlorella that has been milled to break its glycolipoprotein cell wall for improved digestion and absorption.*

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