Food Science and Human Department
Gainesville, Florida, 32611, United States
NCT Number: NCT02778230
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 Me60 year and older
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
A 10-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, gastrointestinal symptoms, stool frequency, and stool consistency (transit time) will be collected by paper questionnaire, and participants will collect a single stool. Dietary data (24-hour dietary recalls) will be obtained via phone interviews 3 times during the baseline period. On or about day 15, participants will attend a study visit and complete the Simplified Nutritional Appetite Questionnaire (SNAQ) and Gastrointestinal Symptom Response Scale (GSRS). 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 appetite, gastrointestinal symptoms, and stool frequency and consistency (transit time). Furthermore, they will complete SNAQ and GSRS after the end of each intervention period. The 24-hour dietary recalls will also be collected 3 times during each of the intervention periods. Participants will undergo an additional 2-week washout period after the second intervention period. During washout periods, the same data will be collected as was done during the baseline and intervention periods.Participants will be asked to collect one stool during pre-baseline and weeks 4, 6, 8 and 10 for a total of 5 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
Snacks (2 baked goods) fortified with 5 g pea hull fiber
Snacks (2 baked goods) without fiber fortification.
Time frame: Changes from baseline to week 4, 6, 8 and 10.
Assesses estimated transit time.
Time frame: Changes from baseline to week 4, 6, 8, and 10
stool frequency
Time frame: Changes from baseline to week 4, 6, 8, and 10
Time frame: Changes from baseline to week 4, 6, 8, and 10
Time frame: Changes from baseline to week 4, 6, 8, and 10
University of Florida
Other
Efficacy of Pea Hull Fibre Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Older Adults.
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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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