Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels

Study Overview
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Brief Summary
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Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. It is not yet known which of these oils has the most beneficial effects in PCOS patients because they have never been compared to each other head to head. In this study the researchers hope to learn more about the effects of these oils on blood sugar and insulin levels.

Detailed Description
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The aim is to investigate whether n-3 PUFA's can be used to prevent postprandial hypoglycemia and its unfavorable consequences, such as stimulation of cortisol and adrenal androgen secretion, in women with polycystic ovarian syndrome.

Official Title
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CCRC: Prevention of Post-Prandial Hypoglycemia Using n-3/n-6 PUFA in PCOS

Conditions
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Polycystic Ovarian Syndrome

Intervention / Treatment
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* Dietary Supplement: Flax Seed Oil
* Dietary Supplement: Fish Oil
* Dietary Supplement: Soybean Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females ages 18-45 Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome Exclusion Criteria: Use of oral contraceptives Impaired glucose tolerance Diabetes mellitus, and any other systemic illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication Schizophrenia Having a pacemaker Current viral infection Smoking alcohol intake (more than 2 drinks/week)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. | Dietary Supplement: Flax Seed Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>Dietary Supplement: Fish Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>Dietary Supplement: Soybean Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>|
| Active Comparator: 2<br>Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. | Dietary Supplement: Flax Seed Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>Dietary Supplement: Fish Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>Dietary Supplement: Soybean Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>|
| Active Comparator: 3<br>Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. | Dietary Supplement: Flax Seed Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed oil, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>Dietary Supplement: Fish Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>Dietary Supplement: Soybean Oil<br>* Subject will follow their usual diet for 4 weeks, at week 6 they will be randomized to receive either flax seed, fish oil, or soybean oil capsules for 6 weeks. They will take six capsules orally six times a day for a total of six weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We hope to learn more about the effects of fish oil, flax seed oil, and soybean oil, on blood sugar and insulin levels in PCOS patients |  | 3 years |