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

Polycystic Ovarian Syndrome Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579540
• Other study ID #: 200715060
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: May 25, 2017
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• 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. They will take six capsules orally six times a day for a total of six weeks.
• Fish Oil
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.
• Soybean Oil
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.

Locations

Country	Name	City	State
United States	UC Davis	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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