Clinical trial NCT01079845: A Cooking and Eating Study
Official title: Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Diet
Nutrition
Adolescent
Young Adult
Overweight
Obesity
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2010-03-03
Enrollment: 19
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Bioavailable Testosterone
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Other Biochemical and Clinical Signs of Hyperandrogenism
timeFrame: Baseline, 6 months
measure: Insulin Sensitivity and Beta-cell Function
timeFrame: Baseline, 6 months
measure: Risk for Cardiovascular Disease
timeFrame: Baseline, 6 months
measure: Body Weight and Composition
timeFrame: Baseline, 6 months
measure: Cyclicity of Menstrual Periods
timeFrame: Monthly
measure: Quality of Life
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Cara B. Ebbeling, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1001/archpedi.157.8.773.
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. doi: 10.1210/jcem.87.3.8305.