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

December 17, 2007
August 1, 2008
April 2006
July 2008   (final data collection date for primary outcome measure)
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 ]
We 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 ]
Complete list of historical versions of study NCT00579904 on ClinicalTrials.gov Archive Site
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CCRC: The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome (PCOS)
CCRC: Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • 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.
  • 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.
  • Active Comparator: walnuts
    Patients will be randomized to receive walnuts
    Intervention: Dietary Supplement: walnuts
  • Active Comparator: almonds
    Patients will be randomized to receive almonds
    Intervention: Dietary Supplement: almonds
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
July 2008
July 2008   (final data collection date for primary outcome measure)

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%.
Female
18 Years to 45 Years
No
Contact: Dumindra D Gurusinghe, BS (916) 703-5481 dgurusinghe@yahoo.com
Contact: Luisa M Vargas, CCRP (916) 703-5480 mlvargas@ucdavis.edu
United States
 
NCT00579904
200513651-3
Yes
Sidika Kasim-Karakas, UC Davis
University of California, Davis
  • National Institutes of Health (NIH)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Sidika E Kasim-Karakas, MD University of California, Davis
University of California, Davis
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP