Clinical trial · Interventional
A Reduced Carbohydrate Diet Intervention for Polycystic Ovary Syndrome (PCOS)
A Reduced Carbohydrate Diet Intervention for PCOS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reduced Glycemic Load Diet | Dietary Supplement | — | UNRESOLVED |
| Standard Diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Reduced Glycemic Load Diet
- description
- 36-40% fat; 40-42% carbohydrate; 18-22% protein Glycemic Load \<=46 per 1000 calories
- interventionNames
- Dietary Supplement: Reduced Glycemic Load Diet
- type
- OTHER
- label
- Standard Diet
- description
- 25-27% fat; 55-57% carbohydrate; 18-22% protein Glycemic Load \>=77 per 1000 calories
- interventionNames
- Dietary Supplement: Standard Diet
Primary outcomes (1)
- measure
- Improving reproductive and metabolic outcomes of women with PCOS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDDouglas 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 16500338
- DERIVEDHoover 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 33491091
- DERIVEDGower 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 25527677