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CCRC: Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS


N/A
18 Years
45 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Insulin Resistance

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Trial Information

CCRC: Walnuts, Walnut-Oil, Glucose Homeostasis, 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.


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%.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Sidika E Kasim-Karakas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Institutional Review Board

Study ID:

200513651-3

NCT ID:

NCT00579904

Start Date:

April 2006

Completion Date:

July 2008

Related Keywords:

  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • PCOS
  • polycystic ovary syndrome
  • insulin resistance
  • fish oil
  • walnut-oil
  • walnuts
  • almonds
  • monounsaturated fats
  • polyunsaturated fats
  • MUFA
  • PUFA
  • Insulin Resistance
  • Polycystic Ovary Syndrome

Name

Location
Clinical and Translational Science Center Clinical Resources Center Mather, California  95655