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

NCT02190097 | Completed

• 1 other identifier: 14-13770
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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

Polycystic Ovarian Syndrome

Keywords

PCOS; insulin sensitivity; paleolithic diet

Outcome Measures

Primary Outcomes (1)

• menstrual cycle frequency

  questionnaires, ovarian ultrasound for volume

  4 months

Secondary Outcomes (1)

• insulin sensitivity

  4 months

Study Arms (2)

paleolithic diet

EXPERIMENTAL

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

American Diabetes Association diet

ACTIVE COMPARATOR

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

Interventions

Paleolithic diet OTHER

see procedures section for more details

paleolithic diet

American Diabetes Association diet OTHER

see procedures section

American Diabetes Association diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Diet, Paleolithic

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Heather Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: July 15, 2014
• Study Start: January 1, 2015
• Primary Completion: July 29, 2022
• Study Completion: August 29, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)