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

Insulin Resistance Clinical Trial

Official title:

Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579904
• Other study ID #: 200513651
• Secondary ID: R21AT002280
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: April 20, 2017
• Start date: April 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2016
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Polycystic ovary syndrome is a common disease that affects 1 out of 16 women. Metabolic and endocrine abnormalities seen in PCOS include insulin resistance, androgen excess and infertility. This study focuses on the insulin resistance aspect because increased insulin resistance leads to premature onset of impaired glucose tolerance or diabetes whereas decreased insulin resistance reduces androgen excess, improves the ovarian function and increases fertility. Although insulin resistance can be treated with insulin-sensitizing drugs, PCOS clinically manifests during adolescence and the long-term safety of the drug-treatment can be a concern. Thus, improving insulin resistance with effective nutritional approaches would be very desirable. Epidemiological studies and animal experiments suggest that replacement of dietary saturated fats with monounsaturated (MUFA) and polyunsaturated (PUFA) fats improves insulin resistance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of polycystic ovary syndrome

• Body mass index (BMI) 22-52

Exclusion Criteria:

• 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)

• The laboratory values used for exclusion of subjects will be fasting glucose > 110 mg/dl, glycosylated hemoglobin (HgBA1) > 6.5%, serum creatinine > 1.5 mg/dl, ALT or AST > 2x the upper limit of normal, cholesterol > 250 mg/dl. The investigators will also exclude subjects with hematocrit < 30%.

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• walnuts
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.
• almonds
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.

Locations

Country	Name	City	State
United States	Clinical and Translational Science Center Clinical Resources Center (CCRC)	Mather	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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