Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels (PCOS)
This study has been completed.
Sponsor:
University of California, Davis
Collaborators:
Information provided by (Responsible Party):
Sidika E. Karakas, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00579540
First received: December 17, 2007
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
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 | Intervention |
|---|---|
|
Polycystic Ovarian Syndrome |
Dietary Supplement: Flax Seed Oil Dietary Supplement: Fish Oil Dietary Supplement: Soybean Oil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | CCRC: Prevention of Post-Prandial Hypoglycemia Using n-3/n-6 PUFA in PCOS |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Sidika E. Karakas, MD, Professor, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00579540 History of Changes |
| Other Study ID Numbers: | 200715060-1 |
| Study First Received: | December 17, 2007 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Hypoglycemia Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013