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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Lynda Frasetto, M.D., University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02190097
First received: June 20, 2014
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PALEOLITHIC VS Healthy ADA DIETS FOR TREATMENT OF POLYCYSTIC OVARIAN SYNDROME (PCOS)

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin sensitivity [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paleolithic
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 18-35
  • Agreeable to avoidance of pregnancy and to use barrier contraception for duration of study
  • BMI between 27 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 ClinicalTrials.gov identifier: NCT02190097

Contacts
Contact: Heather Huddleston, MD 415 353 3040 heather.huddleston@ucsf.edu
Contact: Lynda Frassetto, MD 415 476 6143 lynda.frassetto@ucsf.edu

Locations
United States, California
UCSF Not yet recruiting
San Francisco, California, United States, 94143
Contact: heather huddleston, MD    415-353-3040    heather.huddleston@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Heather Huddleston, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Lynda Frasetto, M.D., Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02190097     History of Changes
Other Study ID Numbers: 14-13770
Study First Received: June 20, 2014
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014