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A Reduced Carbohydrate Diet Intervention for Polycystic Ovary Syndrome (PCOS)

NCT01028989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-03-15

No results posted yet for this study

Summary

Polycystic ovary syndrome (PCOS) affects 5-10% of women of reproductive age, and is associated with infertility, risk for obesity and type 2 diabetes, and impaired quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its symptoms. Manipulation of dietary carbohydrate quantity and quality (glycemic load; GL) may lower insulin and improve both reproductive and metabolic outcomes. The purpose of this study is to determine if a lower GL diet intervention is more effective than a standard (STD) diet in improving reproductive and metabolic outcomes of women with PCOS in the absence of weight loss.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DIETARY_SUPPLEMENT

Reduced Glycemic Load Diet

36-40% fat; 40-42% carbohydrate; 18-22% protein Glycemic Load \<=46 per 1000 calories

DIETARY_SUPPLEMENT

Standard Diet

25-27% fat; 55-57% carbohydrate; 18-22% protein Glycemic Load \>=77 per 1000 calories

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Barbara A Gower, PhD · University of Alabama at Birmingham

  • Fernando Ovalle, MD · University of Alabama at Birmingham

  • G Wright Bates, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028989 on ClinicalTrials.gov