Pilot Study:Role of Dietary Fiber in PCOS Anovulation

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00703092
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 24.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
PCOS	Drug: Fiber-Stat	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study: Role of Dietary Fiber in PCOS Anovulation
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fiber-Stat 2 tablespoons daily	Drug: Fiber-Stat; Liquid fiber supplement, 2 tablespoons twice daily.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. [10 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VCU General Clinical Research Center	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Paulina A Essah, M.D., Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT00703092
• Other Study ID Numbers: HM11246; 2U54HD034449
• First Posted: Jun 23, 2008
• Last Update Posted: Oct 9, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Anovulation

Study Results

Participant Flow

Arm/Group Title	Fiber-Stat
Arm/Group Description	2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Fiber-Stat
Arm/Group Description	2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.

Arm/Group Title	Fiber-Stat
Arm/Group Description	2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
Measure Participants	0

2. Secondary Outcome

Title	Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.
Time Frame	10 months

Outcome Measure Data

Analysis Population Description

This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.

Arm/Group Title	Fiber-Stat
Arm/Group Description	2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
Measure Participants	0

Adverse Events

Arm/Group Title	Fiber-Stat
Arm/Group Description	2 tablespoons daily Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
All Cause Mortality
	Fiber-Stat
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fiber-Stat
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Fiber-Stat
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.