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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00579540
Other study ID # 200715060
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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