NCT00579540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

December 17, 2007

Last Update Submit

May 25, 2017

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

1

ACTIVE COMPARATOR

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 OilDietary Supplement: Fish OilDietary Supplement: Soybean Oil

2

ACTIVE COMPARATOR

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 OilDietary Supplement: Fish OilDietary Supplement: Soybean Oil

3

ACTIVE COMPARATOR

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 OilDietary Supplement: Fish OilDietary Supplement: Soybean Oil

Interventions

Flax Seed OilDIETARY_SUPPLEMENT

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.

123
Fish OilDIETARY_SUPPLEMENT

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.

123
Soybean OilDIETARY_SUPPLEMENT

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.

123

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females ages 18-45
  • Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Linseed OilFish OilsSoybean Oil

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesDietary Fats, UnsaturatedDietary FatsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sidika Kasim-Karakas, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 24, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)