A Randomized, Double-Blind, Placebo-Controlled Study of 3-Acetyl-7-Oxo-Dehydroepiandrosterone in Healthy Overweight Adults

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/m 2 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. Each 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. 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 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.