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Paleo Versus Healthy ADA Diets for Treatment of Polycystic Ovarian Syndrome (PCOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of California, San Francisco
Information provided by (Responsible Party):
Lynda Frasetto, M.D., University of California, San Francisco Identifier:
First received: June 20, 2014
Last updated: October 7, 2016
Last verified: October 2016

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.

Condition Intervention
Polycystic Ovarian Syndrome
Other: Paleolithic diet
Other: American Diabetes Association diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • menstrual cycle frequency [ Time Frame: 4 months ]
    questionnaires, ovarian ultrasound for volume

Secondary Outcome Measures:
  • insulin sensitivity [ Time Frame: 4 months ]
    fasting glucose and insulin, 2 hour oral glucose tolerance tests

Estimated Enrollment: 40
Study Start Date: January 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paleolithic diet
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
Other: Paleolithic diet
see procedures section for more details
Active Comparator: American Diabetes Association diet
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
Other: American Diabetes Association diet
see procedures section

  Show Detailed Description


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02190097

Contact: Heather Huddleston, MD 415 353 3040
Contact: Lynda Frassetto, MD 415 476 6143

United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: heather huddleston, MD    415-353-3040   
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Heather Huddleston, MD University of California, San Francisco
  More Information

Responsible Party: Lynda Frasetto, M.D., Professor, University of California, San Francisco Identifier: NCT02190097     History of Changes
Other Study ID Numbers: 14-13770
Study First Received: June 20, 2014
Last Updated: October 7, 2016
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: would share only with participant, if asked by participant

Keywords provided by University of California, San Francisco:
insulin sensitivity
paleolithic diet

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases processed this record on March 28, 2017