Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

NCT00693082 | Terminated Phase 2 DMC

• 1 other identifier: Pro00000854
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovarian Syndrome

Keywords

PCOS; flaxseed

Outcome Measures

Primary Outcomes (1)

• To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.

  baseline, 12 weeks, 24 weeks

Study Arms (1)

1

EXPERIMENTAL

Dietary Supplement: flaxseed

Interventions

flaxseed DIETARY_SUPPLEMENT

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).

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Univeristy Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Susan M Schneider, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 6, 2008
• Study Start: August 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 20, 2012

Record last verified: 2012-11

Locations

US (1)