PCOS
Conditions
Brief summary
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
Detailed description
We hypothesize that 6 months of fiber supplementation will improve ovulation in women with PCOS by improving insulin sensitivity independent of weight loss. In this pilot study, we will determine the feasibility of conducting a larger double-blind, randomized trial in women with PCOS to test this hypothesis. We will evaluate 15 women over a 10-month period, starting with a 4-month intervention-free observation period to determine the effect on ovulation of adding up to 22g/day of fiber supplementation to their usual weight-maintenance diets (to achieve 28-36 g fiber/day assuming baseline dietary fiber intake, could feasibly be translated into clinical practice.
Interventions
DRUGFiber-Stat
Liquid fiber supplement, 2 tablespoons twice daily.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45 * Less than or equal to 8 periods annually * elevated serum free testosterone concentrations * normal thyroid function tests and serum prolactin * exclusion of late-onset adrenal hyperplasia * acceptable health based on interview, medical history,physical examination, and lab tests * ability to comply with the requirements of the study * ability and willingness to provide signed, witnessed informed consent
Exclusion criteria
* Diabetes mellitus * Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease * high blood pressure * current or recent(within 2 months prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives,metformin,thiazolidinediones,glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone,flutamide,etc) * documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism * ingestion of any investigational drugs within 4 weeks prior to study onset * pregnancy or lactation(less than or equal to 6 weeks postpartum)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety. | 10 months |
Secondary
| Measure | Time frame |
|---|---|
| Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. | 10 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fiber-Stat 2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Fiber-Stat |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.
Time frame: 10 months
Population: This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.
Secondary
Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.
Time frame: 10 months
Population: This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.