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

Not Applicable

Completed

• Conditions: Polycystic Ovarian Syndrome
• Interventions: Dietary Supplement: Flax Seed Oil; Dietary Supplement: Fish Oil; Dietary Supplement: Soybean Oil

• Registration Number: NCT00579540
• Lead Sponsor: University of California, Davis

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Females ages 18-45
• Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Flax Seed Oil	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.
1	Flax Seed Oil	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.
2	Soybean Oil	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.
3	Fish Oil	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.
1	Soybean Oil	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.
1	Fish Oil	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.
2	Fish Oil	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.
3	Soybean Oil	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.
3	Flax Seed Oil	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UC Davis; 🇺🇸 Sacramento, California, United States