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Research Articles
7-Keto DHEAObjectives: To evaluate the safety and pharmacokinetics of 3-acetyl-7-oxo-DHEA (3ß-acetoxyandrost-5-en-7, 17-dione) given orally. Method: The participants received placebo (n=6) or 3-acetyl-7-oxo-DHEA (n=16) at 50mg/d for 7 days followed by a 7-day washout; 100mg/d for 7 days followed by a 7-day washout; and 200mg/d for 28 days. Results: There were no differences in the clinical laboratory values or in reported minor adverse experiences, between treatment and placebo groups. In general, blood hormone concentrations were unaffected by the treatment with 3ß-acetyl-7-oxo-DHEA and remained within the normal range. No changes in vital signs, blood chemistry or urinalysis occurred during treatment with 3ß-acetyl-7-oxo-DHEA compared to placebo. The administered steroid was not detected in the blood but was rapidly converted to 7-oxo-DHEA-S, the concentrations of which were proportional to dose. This steroid sulfate did not accumulate; plasma concentrations 12 hours after the 3ß-acetyl-7-oxo-DHEA dose at 7 and 28 days on the 200mg/d dose were 15.8 and 16.3 µg/L respectively. The mean time to peak plasma level of 7-oxo-DHEA-S was 2.2 hours; the mean half life was 2.17 hours. The apparent clearance averaged 172 L/h, and the apparent mean volume of distribution was 540 L. Conclusions: These results indicate that 3ß-acetyl-7-oxo-DHEA is safe and well tolerated in normal healthy men at doses up to 200 mg/d for 4 weeks.
Douglas S. Kalman, Carlon M. Colker, Melissa A. Swain, Georgeann C. Torina, and Qiuhu Shi Peak Wellness, Inc., and Greenwich Hospital, Greenwich, Connecticut, and North Shore University Hospital, Manhassett, New York ABSTRACT Objective: The purpose of this study was to determine the effects of 3-acetyl-7-oxo-dehydroepiandrosterone (7-oxo-DHEA) in healthy overweight adults. Methods: In a 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/m2 were randomly divided into 2 groups of 15: Group 1 received 7-oxo DHEA 100mg twice daily and Group 2 received placebo for 8 weeks. All subjects participated in an exercise-training program 3 times per week. Each exercise session consisted of 60 minutes of cross-training (aerobic and anaerobic exercise) under the supervision of an exercise physiologist. ~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. Results: 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 -0.57%; P = 0.02). The rate of change in body fat per 4-week interval in Group 1 was 3.1 times that in Group 2 (-0.88% vs -0.28%; P < 0.01). Group 1 also experienced a significant increase in triiodothyronine (T3) levels compared with Group 2 over the 8-week study period (+17.88 ng/dL vs 2.75 ng/dL; P = 0.04). 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. Conclusions: 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. In addition, 7-oxo-DHEA significantly elevated T3 levels but did not affect TSH or T4 levels, indicating that it does not adversely affect thyroid function in the short term. Current Therapeutic Research Vol. 61(7), and pp 435-442, Copyright 2000 by Excerpta Medica, Inc.
C Colker, M.D, G Torina, M Swain, D Kalman. Department of Medicine, Greenwich Hospital, Peak Wellness, Inc, Greenwich, CT 06830 3-Acetyl-7-oxo-dehydroepiandrosterone (7-Keto™) has been shown to normalize an induced hypothyroid state in lab animals and is also known to promote futile cycling. Regular exercise is known to help promote and maintain weight loss. Based on this information, 30 overweight (BMI 31.9 &#plusmn; 6.2) adults (Age 44.5 &#plusmn; 11.5) were randomized into a prospective, double-blind, placebo controlled eight week study. Fifteen subjects received 7-Keto™ 100 mg twice per day whereas the other 15 subjects received a matching placebo. All subjects exercised three times per week, 60 minutes per session of cross-training (aerobic and anaerobic) under the supervision of an exercise physiologist. The exercise plus 7-Keto™ group lost a significant amount of body weight as compared with the exercise plus placebo group (-2.88 kg, p=0.012). In terms of actual body composition changes, the exercise plus 7-Keto™ group lost 1.8% body fat as compared to 0.57% for the placebo group (p=0.02). In terms of effects on the thyroid, triiodothyronine (T3) activity increased significantly in the group receiving 7-Keto™ and not the placebo (+17.88 ng/dl vs. 2.75 ng/dl; p<0.05), there were no significant changes in either TSH or T4. There were no significant changes in blood sugar, testosterone, estradiol, liver, renal function tests, vital signs, or overall caloric intake over the eight week study. Nor were there any subjective adverse effects reported throughout the study. These results indicate that one hour of cross-training three times per week supplemented with 200 mg of 7-Keto™ per day yields a significant reduction in both body weight and body fat. Journal of Exercise Physiology online, ISSN 1097-9751, Volume 2, Number 4, October 1999.
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