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

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT00579540

Collaborator

National Institutes of Health (NIH) (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome	Dietary Supplement: Flax Seed Oil Dietary Supplement: Fish Oil Dietary Supplement: Soybean Oil	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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 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. Dietary Supplement: 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. Dietary Supplement: 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.
Active Comparator: 2 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 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. Dietary Supplement: 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. Dietary Supplement: 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.
Active Comparator: 3 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 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. Dietary Supplement: 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. Dietary Supplement: 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.

Arm

Intervention/Treatment

Active Comparator: 1

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

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.

Dietary Supplement: 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.

Dietary Supplement: Soybean Oil

Active Comparator: 2

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

Dietary Supplement: Fish Oil

Dietary Supplement: Soybean Oil

Active Comparator: 3

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

Dietary Supplement: Fish Oil

Dietary Supplement: Soybean Oil

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis	Sacramento	California	United States	95817

Sponsors and Collaborators

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

Investigators

Principal Investigator: Sidika Kasim-Karakas, MD, UC Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT00579540

Other Study ID Numbers:

200715060

First Posted:

Dec 24, 2007

Last Update Posted:

May 30, 2017

Last Verified:

May 1, 2017

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Study Results

No Results Posted as of May 30, 2017