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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54HD034449 | U.S. NIH Grant/Contract | View source |
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P.I. left University. Study terminated
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber-Stat | Experimental | 2 tablespoons daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber-Stat | Drug | Liquid fiber supplement, 2 tablespoons twice daily. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. | 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulina A Essah, M.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VCU General Clinical Research Center | Richmond | Virginia | 23298 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fiber-Stat | 2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fiber-Stat | 2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This study was terminated early due to lack of enrollment. No assays were run so there is no data to report. | Posted | 10 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fiber-Stat | 2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Nestler | Virginia Commonwealth University | 804-828-3389 | jnestler@mcvh-vcu.edu |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. | This study was terminated early due to lack of enrollment. No assays were run so there is no data to report. | Posted | 10 months |
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| 0 |
| 2 |
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