A Cooking and Eating Study

Not Applicable

Terminated

• Conditions: Polycystic Ovary Syndrome
• Interventions: Behavioral: Nutrition Education, Dietary Counseling, and Cooking

• Registration Number: NCT01079845
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Study Start: 2010-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-glycemic Load Diet	Nutrition Education, Dietary Counseling, and Cooking	-
Low-fat Diet	Nutrition Education, Dietary Counseling, and Cooking	-

Primary Outcome Measures

Name	Time	Method
Bioavailable Testosterone	Baseline, 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States