Efficacy of Pea Hull Fiber - Phase 2

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Control; Dietary Supplement: Pea Fiber

• Registration Number: NCT03016065
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota composition and activity.

Detailed Description

An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull fiber. Participants will complete a 2-week baseline period during which appetite, stool frequency, and stool consistency (transit time) will be collected by an online questionnaire, and participants will collect a single stool. Dietary data (Automated Self-Administered 24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week control period, and snacks with added pea hull fiber for a 2-week treatment period separated by a 2-week washout period. In both intervention periods, participants will complete daily questionnaires to assess stool frequency and consistency (transit time). An online questionnaire assessing appetite will be administered once per week. The GSRS will be competed at each study visit. During washout periods, the same data will be collected as will be done during the baseline and intervention periods. Participants will be asked to collect one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples will be analyzed for changes in the microbiota.

Study Timeline

• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Study Start: 2017-03-29
• Primary Completion: 2019-12-15
• Status Verified: 2022-11
• Study Completion: 2022-11-15
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Control	Control snacks will provided for 2 weeks, followed by a two-week washout, and snacks with 10 g/d of pea fiber for 2 weeks.
Pea Fiber	Pea Fiber	Snacks fortified with 10 g of pea hull fiber will be administered for two weeks, followed by a two-week washout, and a two-week period with control snacks.

Primary Outcome Measures

Name	Time	Method
Change in Modified Bristol Stool Form score	Change from baseline at weeks 4, 6 and 8	Stool consistency rating by Modified Bristol Stool Form for children

Secondary Outcome Measures

Name	Time	Method
Change in number of bowel movements per week	Change from baseline at weeks 4, 6 and 8	Stool frequency per week

Trial Locations

Locations (1)

University of Florida, Food Science and Human Nutrition Dept; 🇺🇸 Gainesville, Florida, United States