Clinical Efficacy Studies

Two independently conducted clinical trials support the effectiveness of 7-Oxo DHEA  for weight loss. Both trials were double-blind and placebo-controlled. Subjects were controlled for diet, exercise and body water, so that the true weight loss effect of 7-Oxo DHEA  could be isolated. Both studies showed a statistically and clinically significant reduction of weight through the use of 7-Oxo DHEA  versus placebo. Both studies have been published in peer-reviewed journals.

A Randomized, Double-Blind, Placebo-Controlled Study of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Healthy Overweight Adults
Douglas S. Kalman, Carlon M. Colker, Melissa A. Swain, Georgeann C. Torina, and Qiuhu Shi
Peak Wellness

The purpose of this study was to determine weight loss of 3-acetyl-7-oxo-dehydroepiandrosterone (7-oxo-DHEA) in healthy overweight adults compared to placebo.

In this double-blind, placebo controlled protocol, 30 adults (28 women and 2 men; mean age, 44.5 ± 11.5 years) with a mean body mass index of 31.9 ± 6.2 kg/m_ were randomly divided into 2 groups of 15: Group 1 received 7-oxo-DHEA 100 mg twice daily and Group 2 received placebo for 8 weeks. All subjects participated in an exercise training program 3 times per week. Exercise session consisted of 60 minutes of cross training (aerobic and anaerobic exercise) under the supervision of an exercise physiologist. In addition, each subject was instructed to follow a diet of ~ 1800 kcal/d (20 kcal/[kg · d]) by a registered dietitian. Subjects received biweekly dietary counseling to encourage compliance. Study participants underwent serum multiple-assay chemistry testing, as well as body composition, blood pressure, and dietary analysis at baseline, week 4 and week 8.

Of the 30 subjects who entered the study, 23 completed the 8-week protocol. Seven subjects dropped out for personal reasons unrelated to the study. Group 1 lost a significant amount of body weight compared with Group 2 (-2.88 kg vs – 0.97 kg; P = 0.01) over the 8 weeks. Group 1 also achieved a significant reduction in body fat compared with Group 2 (-1.8% vs –0.28%; P < 0.01). There were no significant changes in levels of thyroid-stimulating hormone (TSH) or thyroxine (T4) in either group. In addition, no significant changes were observed in vital signs, blood sugar, testosterone and estradiol levels, liver and renal function, or overall caloric intake during the study. No subjective adverse effects were reported throughout the study.

The results of the study suggest that 7-oxo-DHEA combined with moderate exercise and a reduced-calorie diet significantly reduces body weight and body fat compared with exercise and a reduced-calorie diet alone.

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The Effect of 7-Oxo DHEA  Naturalean™ on Weight Loss: A Randomized, Double Blind, Placebo Controlled Trial
John L. Zenk, MD, Tami R. Helmer, MD, Laurie J. Kassen, LD, RD, and Michael A. Kuskowski, PhD Minnesota Applied Research Center

A natural metabolite of dehydroepiandrosterone (DHEA), 3-acetyl-7-oxodehydroepiandrosterone (7-oxo DHEA), has been shown to be effective in enhancing weight loss when combined with a diet and exercise program.

This study assessed the effects of a formula containing 7-oxo DHEA, (200mg/day) on weight loss, body composition, and basal metabolic rate (BMR) in overweight patients following a weight-reduction diet and exercise regimen.

In this prospective, randomized, double-blind, placebo-controlled trial, healthy, overweight adults were given the formula containing 7-oxo DHEA or a placebo and followed a calorie restricted diet (105 kJ/kg) and an exercise program for 8 weeks. Body weight, body composition (by bioelectric impedance), and BMR (by indirect calorimetry) were measured at baseline, week 4 and week 8. A thyroid panel was done at baseline and
week 8.

Of 35 healthy, overweight adults enrolled, 33 completed the study (12 men, 21 women; age, 40-69 years; body mass index [BMI], 27.0-42.7 kg/m2). Patients taking 7-Oxo DHEA  Naturalean lost significantly more weight after 8 weeks than those taking placebo (mean ± SD loss, 2.15 ± 2.38 kg and 0.72 ± 2.12 kg, respectively) (P=0.038). The change in BMI in the 7-Oxo DHEA  Naturalean-treated group was significant compared with the change in the placebo group (mean ± SD decrease, 0.71 ± 0.79 kg/m2 and 0.01 ± 1.05 kg/m2, respectively) (P=0.036). There were no other statistically significant differences in any of the other measured variables. 7-Oxo DHEA  Naturalean was well tolerated, and there were no significant adverse events.

This formula containing 7-oxo DHEA when combined with a reduced calorie diet and an exercise program resulted in a significant weight loss compared with diet and exercise alone.

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These statements have not been evaluated by the FDA. This product is not intended to treat, diagnose, cure, mitigate or prevent any disease. Consult with your doctor before starting any diet or exercise program. *Avg. weight loss 6.35 lbs in 8 weeks with same formula as Ultraburn vs 2.14 pounds with placebo. Both groups dieted and exercised.

 


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Many weight loss ingredients have come and gone over the past five years. Most have faded in popularity due to many factors including lack of results, enforcement actions by the Federal Trade Commission due to lack of claims substantiation, and concerns over safety and liability. 7-Oxo DHEA continues to grow as a top selling weight loss ingredient for today’s nutraceutical manufacturers because it offers the published documentation necessary in the weight loss marketplace. In addition, it can back up its claims for safe and effective weight loss, which is critical for longevity of any dietary ingredient.