- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00693082
Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
November 19, 2012 updated by: Duke University
The overall aim of this study is to explore the effects of flaxseed supplementation and determine whether it is a feasible and potentially effective dietary intervention among women with polycystic ovarian syndrome (PCOS).
Women, ages 18-45, with clinically confirmed PCOS (N=20) will be scheduled for baseline measures and then instructed and given supplies necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months, whereupon follow-up measures will be taken.
Subjects will be asked to resume their typical (unsupplemented) diet for another three months and a second set of follow-up measures will be taken.
Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and menstrual cyclicity will be compared to levels at 3 and 6 month follow-up.
The overall hypothesis (based upon our work in men at risk for prostate cancer and data from one case-study conducted in a woman with confirmed PCOS) is that during the time women receive flaxseed supplementation they will experience reduced serum levels of testosterone, and total and LDL cholesterol, as well as clinical evidence of hirsutism.
Given the pilot nature of this study, statistical analyses will be limited to simple descriptive statistics.
We have observed no negative side effects, other than minor gastro-intestinal occurrences (i.e., temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with flaxseed supplementation in our previous studies either with short or long-term use.
Flaxseed supplementation will be discontinued if indicated and the events reported to the institutional review board.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Univeristy Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- limited to women aged 18-45
- diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually), Ferriman-Gallwey score > 8, and/or hyperandrogenemia defined as bioavailable T>8.4ng/dL (Zawdaki & Dunaif 1992)
- mentally competent
- English speaking/writing
- telephone access and/or email access
Exclusion Criteria:
- Use of oral contraceptives, spironolactone or insulin-sensitizing agents within the past 3 months;
- Long-term or chronic use of oral antibiotics;
- Diagnoses of hyperprolactinemia, thyroid abnormalities, or nonclassic adrenal hyperplasia;
- Hysterectomy;
- Onset of menopause;
- Pregnancy/Lactation;
- Consumption of flaxseed within the past month; and
- Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1 tablespoon a day for first three days, increasing to two tablespoons a day for the next three days.
On the 7th day start with 3 tablespoons per day and maintain dose throughout the duration of the study (11 weeks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.
Time Frame: baseline, 12 weeks, 24 weeks
|
baseline, 12 weeks, 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan M Schneider, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 5, 2008
First Posted (Estimate)
June 6, 2008
Study Record Updates
Last Update Posted (Estimate)
November 20, 2012
Last Update Submitted That Met QC Criteria
November 19, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00000854
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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