Clinical trial · Interventional
Paleo Versus Healthy ADA Diets for Treatment of Polycystic Ovarian Syndrome (PCOS)
PALEOLITHIC VS Healthy ADA DIETS FOR TREATMENT OF POLYCYSTIC OVARIAN SYNDROME (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) is a syndrome which includes elevated androgen levels, irregular menstrual cycles and insulin resistance. Standard treatments, which include weight loss and medications to improve insulin secretion are only partly successful, and may require that young women take medications for decades. The study investigators have been evaluating the effects of specific diets on insulin resistance in healthy volunteers and subjects with type 2 diabetes, and have found that subjects with insulin resistance seem to respond particularly well to these diet regimens. Volunteers with PCOS are being asked to participate to see if following these diets can help regularize your menstrual cycles. The results of this study may help improve fertility treatments for women with PCOS.
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 Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| American Diabetes Association diet | Other | — | UNRESOLVED |
| Paleolithic diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- paleolithic diet
- description
- subjects in this arm are given detailed instructions and coaching in following a paleolithic type diet for 4 months, with the option to continue for another 4 months. studies of ovarian and metabolic parameters will be done at baseline, 2 and 4 months
- interventionNames
- Other: Paleolithic diet
- type
- ACTIVE_COMPARATOR
- label
- American Diabetes Association diet
- description
- subjects in this arm are given detailed instructions and coaching in following an ADA type diet for 4 months, with the option to switch over to the paleolithic diet arm for another 4 months. studies of ovarian and metabolic parameters will be done at baseline, 2 and 4 months
- interventionNames
- Other: American Diabetes Association diet
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion in the study is restricted to reproductive age women with PCOS * Chronic oligo/anovulation defined as an intermenstrual interval of \>45 days and/or \< 8 menstrual cycles/year and evidence of either hyperandrogenemia (elevation of total or free testosterone above the normal range for women) and/or clinical hyperandrogenism (hirsutism and/or acne) * Age 18-40 * Agreeable to avoidance of pregnancy and to use barrier contraception for duration of study * BMI between 18 to 40 kg/m2 Exclusion Criteria: * Other abnormalities which might lead to anovulation: hyperprolactinemia, thyroid dysfunction and other causes of hyperandrogenemia including late onset congenital hyperplasia * Evidence of diabetes based on a fasting glucose \>126 mg/dl or OGTT * Use of medications and/or supplements that influence either ovarian function or insulin sensitivity, within 2 months: including oral contraceptive pills, hormonal implants, anti-androgens, antipsychotics or antihypertensives metformin, glucocorticoids, and/or health food remedies other than multi-vitamins and calcium; * Subjects who are on oral contraception, metformin, or nutritional supplements must agree to discontinue these drugs and undergo an 8 week washout period before the tests are performed * Alcohol usage more than 7 drinks/week * Hemoglobin \< 10 grams * Smokers * Inability to understand the study goals and protocols and the consent form * Any subject, who in the opinion of the investigators, does not qualify for the study
References
Publications (0)
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