NCT01028989

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

1.7 years

First QC Date

December 8, 2009

Last Update Submit

March 13, 2013

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary SyndromeInsulinDietGlycemic Load

Outcome Measures

Primary Outcomes (1)

  • Improving reproductive and metabolic outcomes of women with PCOS

    8 weeks

Secondary Outcomes (1)

  • The lower Glycemic Load diet will increase perceived fullness and decrease hunger, effects mediated via gut hormones.

    8 weeks

Study Arms (2)

Reduced Glycemic Load Diet

OTHER

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

Dietary Supplement: Reduced Glycemic Load Diet

Standard Diet

OTHER

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

Dietary Supplement: Standard Diet

Interventions

Reduced Glycemic Load DietDIETARY_SUPPLEMENT

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

Reduced Glycemic Load Diet
Standard DietDIETARY_SUPPLEMENT

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

Standard Diet

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

  • 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. doi: 10.1016/j.fertnstert.2005.08.045.

    PMID: 16500338BACKGROUND

  • Hoover SE, Gower BA, Cedillo YE, Chandler-Laney PC, Deemer SE, Goss AM. Changes in Ghrelin and Glucagon following a Low Glycemic Load Diet in Women with PCOS. J Clin Endocrinol Metab. 2021 Apr 23;106(5):e2151-e2161. doi: 10.1210/clinem/dgab028.

    PMID: 33491091DERIVED

  • Gower BA, Goss AM. A lower-carbohydrate, higher-fat diet reduces abdominal and intermuscular fat and increases insulin sensitivity in adults at risk of type 2 diabetes. J Nutr. 2015 Jan;145(1):177S-83S. doi: 10.3945/jn.114.195065. Epub 2014 Dec 3.

    PMID: 25527677DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

US(1)