Trial record 14 of 27 for:    nichd Polycystic Ovary Syndrome (PCOS)

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Gower, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01028989
First received: December 8, 2009
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Dietary Supplement: Reduced Glycemic Load Diet
Dietary Supplement: Standard Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Reduced Carbohydrate Diet Intervention for PCOS

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Improving reproductive and metabolic outcomes of women with PCOS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The lower Glycemic Load diet will increase perceived fullness and decrease hunger, effects mediated via gut hormones. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: December 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reduced Glycemic Load Diet

36-40% fat; 40-42% carbohydrate; 18-22% protein

Glycemic Load <=46 per 1000 calories

Dietary Supplement: Reduced Glycemic Load Diet

36-40% fat; 40-42% carbohydrate; 18-22% protein

Glycemic Load <=46 per 1000 calories

Standard Diet

25-27% fat; 55-57% carbohydrate; 18-22% protein

Glycemic Load >=77 per 1000 calories

Dietary Supplement: Standard Diet

25-27% fat; 55-57% carbohydrate; 18-22% protein

Glycemic Load >=77 per 1000 calories


Detailed Description:

Polycystic ovary syndrome (PCOS) is a heterogeneous syndrome affecting 5-10% of women of reproductive age. It is characterized by elevated circulating insulin, reduced insulin sensitivity, infertility, hyperandrogenism, and a multitude of symptoms that result in a decreased quality of life. The elevated insulin characteristic of PCOS is likely to play a major role in its pathogenesis by reducing insulin sensitivity and stimulating testosterone (T) production and increasing its free fraction. Although many women with PCOS are overweight/obese (10-50%), those who are non-obese suffer from the same symptoms as their obese counterparts. Thus, it is likely that the metabolic disturbances associated with PCOS predispose to weight gain, which in turn exacerbates PCOS by worsening insulin resistance. Manipulation of dietary carbohydrate quantity and quality (glycemic load; GL) may lower insulin and improve both reproductive and metabolic outcomes. No study has tested the efficacy of a lower GL diet among non-obese women with PCOS.

The Specific Aim of this proposal 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 (both normal-weight and overweight/obese). We hypothesize that, in the absence of weight change, the lower GL diet will be more effective than the STD diet in decreasing insulin secretion, increasing insulin sensitivity, decreasing free T, decreasing fat from metabolically harmful sites, decreasing inflammation, and improving menstrual cyclicity and ovulation. Further, the lower GL diet will increase perceived fullness and decrease hunger, effects mediated via gut hormones.

Development of a diet that optimizes reproductive and metabolic health among women with PCOS will reduce reliance on pharmacologic treatments and improve quality of life, even in the absence of weight loss. This project is novel in being the first to conduct a highly controlled nutrition intervention in non-obese women with PCOS under weight stable conditions, utilizing robust measures of insulin secretion and action, fat distribution, inflammation, hunger/fullness, the gut hormone profile, and reproductive function. The results from this study can be used as a starting point from which to explore optimal diets for overweight women with PCOS.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with PCOS
  • Body mass index 18.5-35 kg/m2

Exclusion Criteria:

  • Cushing's syndrome
  • Type 1 or 2 diabetes
  • Self-reported claustrophobia
  • Androgenic tumors or adrenal hyperplasia
  • Hyperprolactinemia
  • Implanted metal items
  • Use of metformin or other diabetes drug
  • Women using oral contraceptives will not be excluded, but will be required to discontinue use of these agents 3 months prior to testing.
  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: NCT01028989

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Barbara A Gower, PhD University of Alabama at Birmingham
Principal Investigator: Fernando Ovalle, MD University of Alabama at Birmingham
Principal Investigator: G Wright Bates, MD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Barbara Gower, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01028989     History of Changes
Other Study ID Numbers: F090407003, 1R01HD054960-01A2
Study First Received: December 8, 2009
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Polycystic Ovary Syndrome
Insulin
Diet
Glycemic Load

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

ClinicalTrials.gov processed this record on October 23, 2014