Back to resultsCompare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels (PCOS)
Primary Purpose
Polycystic Ovarian Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flax Seed Oil
Fish Oil
Soybean Oil
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovarian Syndrome
Eligibility Criteria
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)
Sites / Locations
- UC Davis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
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.
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.
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.
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00579540
First Posted
December 17, 2007
Last Updated
May 25, 2017
Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00579540
Brief Title
Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels
Acronym
PCOS
Official Title
CCRC: Prevention of Post-Prandial Hypoglycemia Using n-3/n-6 PUFA in PCOS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Flax Seed Oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Soybean Oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidika Kasim-Karakas, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels
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