CCRC: The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome (PCOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00579904
First received: December 17, 2007
Last updated: August 1, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Insulin Resistance
Dietary Supplement: walnuts
Dietary Supplement: almonds

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CCRC: Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: April 2006
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: walnuts
Patients will be randomized to receive walnuts
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.
Active Comparator: almonds
Patients will be randomized to receive almonds
Dietary Supplement: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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%.
  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: NCT00579904

Contacts
Contact: Dumindra D Gurusinghe, BS (916) 703-5481 dgurusinghe@yahoo.com
Contact: Luisa M Vargas, CCRP (916) 703-5480 mlvargas@ucdavis.edu

Locations
United States, California
Clinical and Translational Science Center Clinical Resources Center Recruiting
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Sidika E Kasim-Karakas, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Sidika Kasim-Karakas, UC Davis
ClinicalTrials.gov Identifier: NCT00579904     History of Changes
Other Study ID Numbers: 200513651-3
Study First Received: December 17, 2007
Last Updated: August 1, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
PCOS
polycystic ovary syndrome
insulin resistance
fish oil
walnut-oil
walnuts
almonds
monounsaturated fats
polyunsaturated fats
MUFA
PUFA

Additional relevant MeSH terms:
Ovarian Cysts
Insulin Resistance
Polycystic Ovary Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014