Status:
COMPLETED
Paleo Versus Healthy ADA Diets for Treatment of Polycystic Ovarian Syndrome (PCOS)
Lead Sponsor:
University of California, San Francisco
Conditions:
Polycystic Ovarian Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
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 medication...
Detailed Description
Experimental Design and Methods This is a prospective, open labeled, randomized diet intervention study done on adult participants with PCOS. After signing informed consents, participants will be aske...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02190097
Start Date
January 1 2015
End Date
August 29 2022
Last Update
December 1 2022
Active Locations (1)
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1
UCSF
San Francisco, California, United States, 94143