A Cooking and Eating Study

Polycystic Ovary Syndrome Clinical Trial

— ACES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079845
• Other study ID #: 10-02-0069
• Status: Terminated
• Phase: N/A
• First received: March 2, 2010
• Last updated: February 4, 2015
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: February 2015
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Erratum in: JAMA. 2007 Aug 8;298(6):627. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailable Testosterone		Baseline, 6 months	No
Secondary	Other Biochemical and Clinical Signs of Hyperandrogenism	total and free testosterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), hirsutism, acne	Baseline, 6 months	No
Secondary	Insulin Sensitivity and Beta-cell Function	frequently-sampled oral glucose tolerance test, HbA1c	Baseline, 6 months	No
Secondary	Risk for Cardiovascular Disease	serum levels of HDL cholesterol, LDL cholesterol, triglycerides, and C-reactive protein; blood pressure	Baseline, 6 months	No
Secondary	Body Weight and Composition	body fat percentage and distribution assessed by dual-energy x-ray absorptiometry (DXA), waist circumference	Baseline, 6 months	No
Secondary	Cyclicity of Menstrual Periods		Monthly	No
Secondary	Quality of Life	Questionnaire	Baseline, 6 months	No