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

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Insulin Resistance
Polycystic Ovary Syndrome

Treatments

Dietary Supplement: almonds
Dietary Supplement: walnuts

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00579904
R21AT002280 (U.S. NIH Grant/Contract)
200513651

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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%.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

walnuts
Active Comparator group
Description:
Patients will be randomized to receive walnuts
Treatment:
Dietary Supplement: walnuts
almonds
Active Comparator group
Description:
Patients will be randomized to receive almonds
Treatment:
Dietary Supplement: almonds

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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