Clinical trial NCT00579904: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Keywords: PCOS
polycystic ovary syndrome
insulin resistance
fish oil
walnut-oil
walnuts
almonds
monounsaturated fats
polyunsaturated fats
MUFA
PUFA
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2007-12-24
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%.

Primary outcomes:
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.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mather
country: United States
facility: Clinical and Translational Science Center Clinical Resources Center (CCRC)
state: California
Study officials:
affiliation: University of California, Davis
name: Sidika E Kasim-Karakas, MD
role: PRINCIPAL_INVESTIGATOR
References: