The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome

NCT00579904 | Completed DMC

• 2 other identifiers: 200513651R21AT002280
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients. The hypothesis is that a diet rich in these foods will improve insulin resistance in women with PCOS.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Keywords

PCOS; polycystic ovary syndrome; insulin resistance; fish oil; walnut-oil; walnuts; almonds; monounsaturated fats; polyunsaturated fats; MUFA; PUFA

Outcome Measures

Primary Outcomes (1)

• The investigators hope to learn the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in PCOS patients.

  3 years

Study Arms (2)

walnuts

ACTIVE COMPARATOR

Patients will be randomized to receive walnuts

Dietary Supplement: walnuts

almonds

ACTIVE COMPARATOR

Patients will be randomized to receive almonds

Dietary Supplement: almonds

Interventions

walnuts DIETARY_SUPPLEMENT

Subjects will follow their usual diet for 4 weeks; after that they will be randomized to walnuts. They will eat walnuts once daily for six weeks.

walnuts

almonds DIETARY_SUPPLEMENT

Subjects will follow their usual diet for 4 weeks; after that they will be randomized to almonds. They will eat almonds once daily for six weeks.

almonds

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of polycystic ovary syndrome
• Body mass index (BMI) 22-52

You may not qualify if:

• Habitual dietary intake of less than 30% fat
• Use of oral contraceptives, insulin sensitizers, d-chiro inositol, or any other supplements affecting weight or insulin sensitivity during the preceding two months
• Impaired glucose tolerance
• Diabetes mellitus
• Other system illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
• Smoking, alcohol intake (more than 2 drinks/week)

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Clinical and Translational Science Center Clinical Resources Center (CCRC)

Mather, California, 95655, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

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

Study Officials

• Sidika E Kasim-Karakas, MD

  University of California, Davis

  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: December 17, 2007
• First Posted: December 24, 2007
• Study Start: April 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 24, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)