An interventional study of Pea Fiber and Control in Healthy, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 8 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by University of Florida · Not applicable, Interventional, and Basic science
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.
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.
University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Dietary Supplement: Pea Fiber
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.
Dietary Supplement: Control
Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls
Baked goods (2 snacks) without added fiber
Change in Modified Bristol Stool Form score
Stool consistency rating by Modified Bristol Stool Form for children
Time frame: Change from baseline at weeks 4, 6 and 8
Change in number of bowel movements per week
Stool frequency per week
Time frame: Change from baseline at weeks 4, 6 and 8
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Florida