Flaxseed Lignan (Brevail)

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01396369

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries.

This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome	Drug: Birth control Drug: Birth control plus Brevail	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Birth control	Drug: Birth control In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.
Experimental: Birth control plus Brevail	Drug: Birth control plus Brevail In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.

Arm

Intervention/Treatment

Active Comparator: Birth control

Drug: Birth control

In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.

Experimental: Birth control plus Brevail

Drug: Birth control plus Brevail

Outcome Measures

Primary Outcome Measures

Primary outcomes to assess are the changes of testosterone levels and hirsutism. [up to 6 months]

Secondary Outcome Measures

Secondary outcomes to assess are the lipid profile and estrogen levels. [Up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be 18 to 40 year old female with:
Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score >8, and/or hyperandrogenemia defined as total testosterone >80ng/dl or bioavailable testosterone >8.4 ng/dl.
Mentally competent.

Exclusion Criteria:

Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
Long-term or chronic use of oral antibiotics.
Hysterectomy.
FSH >15.
Pregnancy/lactation.
Consumption of flaxseed within the last month.
Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

Principal Investigator: Sam Kim, MD, The University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT01396369

Other Study ID Numbers:

12459

First Posted:

Jul 18, 2011

Last Update Posted:

Jan 8, 2016

Last Verified:

Jan 1, 2016

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Study Results

No Results Posted as of Jan 8, 2016