University of Florida, Food Science and Human Nutrition Dept
Gainesville, Florida, 32611, United States
NCT Number: NCT03016065
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.
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Notify Me8 year–15 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls
Baked goods (2 snacks) without added fiber
Time frame: Change from baseline at weeks 4, 6 and 8
Stool consistency rating by Modified Bristol Stool Form for children
Time frame: Change from baseline at weeks 4, 6 and 8
Stool frequency per week
University of Florida
Other
Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit in Overweight Children.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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