A Cooking and Eating Study
A Cooking and Eating Study
Background. The polycystic ovary syndrome (PCOS) is a complex hormonal disorder that presents
 in susceptible girls around the time of menarche. Females with PCOS have high levels of
 androgens (e.g., testosterone). While cosmetic appearance (excess facial hair and acne) and
 menstrual disturbances were once considered the primary concerns, emerging data indicate that
 many adolescents and young adults with PCOS are insulin resistant and at increased risk for
 metabolic syndrome and diabetes. The majority of females with PCOS are obese, and excess body
 fat amplifies the severity of the syndrome.

 Dietary intervention is considered an important component of treatment for PCOS. However, a
 consensus statement regarding optimal nutrient composition for treating adolescents and young
 adults with PCOS has not been published because data are lacking to provide a foundation for
 such a statement. Recognizing increased risk for diabetes in patients with PCOS, many
 practitioners employ a low-fat diet as prescribed in the Diabetes Prevention Program (DPP)
 for weight loss and control of symptoms.

 Objective and Hypothesis. The purpose of this research study is to compare different diets
 for treating PCOS. We hypothesize that a low-glycemic load diet - designed to lower blood
 levels of glucose and insulin - will be more beneficial than a low-fat diet in obese
 adolescents and young adults with PCOS.

 Design. We propose a 6-month study in which 50 obese females with PCOS (ages 13 to 21 years)
 will be assigned to receive one of two dietary treatments, with the goal of retaining 40
 participants. Group assignment will be at random. One of the treatments will be a
 low-glycemic load diet, and the other treatment will be a low-fat diet (modeled after the DPP
 diet). Participants in both groups will receive individual nutrition education and dietary
 counseling with a registered dietitian (clinic visits, telephone calls) and cooking workshops
 with a chef. The purpose of the cooking workshops will be to enhance compliance with diet
 prescriptions, beyond what can be achieved by nutrition education and dietary counseling in a
 conventional clinic setting.

 The primary outcome will be bioavailable testosterone (form of testosterone that causes
 symptoms of PCOS). Secondary outcomes will include other blood tests to evaluate further high
 androgen levels (total testosterone, free testosterone, sex hormone binding globulin,
 dehydroepiandrosterone sulfate), clinical signs of high androgen levels (excess facial hair,
 acne), glucose tolerance and risk for diabetes (determined by blood sugar and insulin
 measurements), risk for cardiovascular disease (based on blood cholesterol and C-reactive
 protein levels and blood pressure), body fat percentage and distribution (measured using
 state-of-the-art dual energy x-ray absorptiometry and waist circumference), menstrual
 cyclicity, and health-related quality of life (evaluated by questionnaire).
Inclusion Criteria:

 -  Diagnosis of PCOS.

 -  Aged 13 to 21 years (and living at home with a parent, only for those <18 years old).

 -  Body mass index (BMI) at or above the 85th percentile.

 -  Access to a working telephone.

 -  At least one parent willing and able to participate in the intervention, only for
 those <18 years old.

 -  Residing in predominately one household (no more than one weekend every two weeks in a
 secondary household).

 -  Medical clearance from the physician who is treating PCOS.

 Exclusion Criteria:

 -  Physician diagnosis of a major medical illness or eating disorder.

 -  Fasting blood glucose at or above 126 mg/dL, indicating diabetes mellitus.

 -  Chronic use of any medication that may affect study outcomes.

 -  Current smoking.

 -  Physical, mental, or cognitive handicaps that prevent participation.

 -  Sister participating in the study.