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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS

Conditions
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Polycystic Ovary Syndrome, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: walnuts
* Dietary Supplement: almonds


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: walnuts<br>Patients will be randomized to receive walnuts | Dietary Supplement: walnuts<br>* 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.<br>|
| Active Comparator: almonds<br>Patients will be randomized to receive almonds | Dietary Supplement: almonds<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigators hope to learn the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in PCOS patients. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, polycystic ovary syndrome, insulin resistance, fish oil, walnut-oil, walnuts, almonds, monounsaturated fats, polyunsaturated fats, MUFA, PUFA