A Cooking and Eating Study

Study Overview
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Brief Summary
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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).

Official Title
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Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Behavioral: Nutrition Education, Dietary Counseling, and Cooking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-glycemic Load Diet<br> | Behavioral: Nutrition Education, Dietary Counseling, and Cooking<br>* Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef<br>|
| Active Comparator: Low-fat Diet<br> | Behavioral: Nutrition Education, Dietary Counseling, and Cooking<br>* Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailable Testosterone |  | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Biochemical and Clinical Signs of Hyperandrogenism | total and free testosterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), hirsutism, acne | Baseline, 6 months | 
| Insulin Sensitivity and Beta-cell Function | frequently-sampled oral glucose tolerance test, HbA1c | Baseline, 6 months | 
| Risk for Cardiovascular Disease | serum levels of HDL cholesterol, LDL cholesterol, triglycerides, and C-reactive protein; blood pressure | Baseline, 6 months | 
| Body Weight and Composition | body fat percentage and distribution assessed by dual-energy x-ray absorptiometry (DXA), waist circumference | Baseline, 6 months | 
| Cyclicity of Menstrual Periods |  | Monthly | 
| Quality of Life | Questionnaire | Baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Nutrition, Adolescent, Young Adult, Overweight, Obesity