A Cooking and Eating Study (ACES)

This study has been terminated.
(For this pilot, we constructed conditional power curves and noted that we would not substantially enhance power by enrolling additional participants.)
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Cara Ebbeling, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01079845
First received: March 2, 2010
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Polycystic Ovary Syndrome
Behavioral: Nutrition Education, Dietary Counseling, and Cooking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-glycemic Load vs. Low-fat Diet for Treating PCOS in Obese Adolescents and Young Adults

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Bioavailable Testosterone [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other Biochemical and Clinical Signs of Hyperandrogenism [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    total and free testosterone, sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), hirsutism, acne

  • Insulin Sensitivity and Beta-cell Function [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    frequently-sampled oral glucose tolerance test, HbA1c

  • Risk for Cardiovascular Disease [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    serum levels of HDL cholesterol, LDL cholesterol, triglycerides, and C-reactive protein; blood pressure

  • Body Weight and Composition [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    body fat percentage and distribution assessed by dual-energy x-ray absorptiometry (DXA), waist circumference

  • Cyclicity of Menstrual Periods [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Questionnaire


Enrollment: 19
Study Start Date: July 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079845

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Thrasher Research Fund
Investigators
Principal Investigator: Cara B. Ebbeling, PhD, MS Children's Hospital Boston
  More Information

Publications:
Responsible Party: Cara Ebbeling, Associate Director, Obesity Prevention Center, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01079845     History of Changes
Other Study ID Numbers: 10-02-0069
Study First Received: March 2, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Diet
Nutrition
Adolescent
Young Adult
Overweight
Obesity

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014