A randomized trial of the effects of two
types of short-term hypocaloric diets on
weight loss in women with polycystic
ovary syndrome
Kelly Stamets, M.D.,a,b Denise S. Taylor, M.S., FR.D.c Allen Kunselman, M.A.,d
Laurence M. Demers, Ph.D.,e Christine L. Pelkman, Ph.D.,f and Richard S. Legro, M.D.a
Department of Obstetrics and Gynecology, Pennsylvania State College of Medicine, Hershey, Pennsylvania
Objective: We performed this study as a pilot experiment to investigate the short term effects of two diets of
varying composition on weight loss as the primary outcome in obese women with polycystic ovary syndrome
(PCOS) seeking fertility.
Design: Randomized clinical trial.
Setting: Academic medical center.
Patient(s): Thirty-five obese women with PCOS.
Intervention(s): We examined the effects of a 1-month dietary intervention on the PCOS phenotype.
Participants were randomized to one of two energy-restricted diets; high protein (HP: 30% protein, 40%
carbohydrate, and 30% fat) or high carbohydrate (HC: 15% protein, 55% carbohydrate, and 30% fat). The fat
content was held constant in both diets.
Main Outcome Measure(s): Primary—change in body weight; Secondary—biometric, hormonal, lipid and
lipoprotein, and markers of glucose homeostasis and energy metabolism.
Result(s): Twenty-six women completed the study. Both the HP (
3.7  1.9 kg) and HC (
4.4  1.5 kg)
diets resulted in significant weight loss, but there was no significant difference in mean weight loss between
the two groups. There were also no differences between diets on a variety of measures including circulating
androgens, measures of glucose metabolism, and leptin. However, the effects of a hypocaloric diet per se on
improving metabolic and reproductive abnormalities in a group of PCOS women were marked by a decline
in circulating androgens (P.03), fasting and area under the curve (AUC) insulins (P.05) on a 3-hour oral
glucose tolerance test (OGTT), and fasting and AUC leptin levels (P.0001). There was a high prevalence
of menstrual bleeding during the trial (14 out of 26 patients).
Conclusion(s): Those who completed the short-term hypocaloric diet had a significant weight loss and a
significant improvement in their reproductive and metabolic abnormalities. There was no increased benefit to
a high-protein diet. Future diet studies evaluating the ideal composition of a hypocaloric diet in women with
PCOS will require a large study population, and will most likely require a multicenter trial. (Fertil Steril

2004;81:630 –7. ©2004 by American Society for Reproductive Medicine.)