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

Primary Purpose

Polycystic Ovary Syndrome, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
walnuts
almonds
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, polycystic ovary syndrome, insulin resistance, fish oil, walnut-oil, walnuts, almonds, monounsaturated fats, polyunsaturated fats, MUFA, PUFA

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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%.

Sites / Locations

  • Clinical and Translational Science Center Clinical Resources Center (CCRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

walnuts

almonds

Arm Description

Patients will be randomized to receive walnuts

Patients will be randomized to receive almonds

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 17, 2007
Last Updated
April 20, 2017
Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00579904
Brief Title
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome
Official Title
Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Insulin Resistance
Keywords
PCOS, polycystic ovary syndrome, insulin resistance, fish oil, walnut-oil, walnuts, almonds, monounsaturated fats, polyunsaturated fats, MUFA, PUFA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
walnuts
Arm Type
Active Comparator
Arm Description
Patients will be randomized to receive walnuts
Arm Title
almonds
Arm Type
Active Comparator
Arm Description
Patients will be randomized to receive almonds
Intervention Type
Dietary Supplement
Intervention Name(s)
walnuts
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
almonds
Intervention Description
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.
Primary Outcome Measure Information:
Title
The investigators hope to learn the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in PCOS patients.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidika E Kasim-Karakas, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Science Center Clinical Resources Center (CCRC)
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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