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

December 8, 2009
March 13, 2013
December 2009
August 2011   (final data collection date for primary outcome measure)
Improving reproductive and metabolic outcomes of women with PCOS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028989 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Reduced Carbohydrate Diet Intervention for Polycystic Ovary Syndrome (PCOS)
A Reduced Carbohydrate Diet Intervention for PCOS

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Polycystic Ovary Syndrome
  • 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

  • Reduced Glycemic Load Diet

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

    Glycemic Load <=46 per 1000 calories

    Intervention: Dietary Supplement: Reduced Glycemic Load Diet
  • Standard Diet

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

    Glycemic Load >=77 per 1000 calories

    Intervention: Dietary Supplement: Standard Diet
Douglas CC, Gower BA, Darnell BE, Ovalle F, Oster RA, Azziz R. Role of diet in the treatment of polycystic ovary syndrome. Fertil Steril. 2006 Mar;85(3):679-88.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Female
19 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028989
F090407003, 1R01HD054960-01A2
No
Barbara Gower, University of Alabama at Birmingham
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
University of Alabama at Birmingham
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP