A Cooking and Eating Study (ACES)

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

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).

Study Overview

• Status: Terminated
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Behavioral: Nutrition Education, Dietary Counseling, and Cooking

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Thrasher Research Fund
• Investigators: Principal Investigator: Cara B. Ebbeling, PhD, MS, Boston Children's Hospital

Publications and helpful links

General Publications

• Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102. doi: 10.1001/jama.297.19.2092. Erratum In: JAMA. 2007 Aug 8;298(6):627.
• Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med. 2003 Aug;157(8):773-9. doi: 10.1001/archpedi.157.8.773.
• Palmert MR, Gordon CM, Kartashov AI, Legro RS, Emans SJ, Dunaif A. Screening for abnormal glucose tolerance in adolescents with polycystic ovary syndrome. J Clin Endocrinol Metab. 2002 Mar;87(3):1017-23. doi: 10.1210/jcem.87.3.8305.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Adolescent; Obesity; Overweight; Nutrition; Diet; Young Adult
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome
• Other Study ID Numbers: 10-02-0069