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| Name | Class |
|---|---|
| Saskatchewan Pulse Growers | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pea Fiber | Experimental | 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. |
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| Control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pea Fiber | Dietary Supplement | Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Bristol Stool Form score | Stool consistency rating by Modified Bristol Stool Form for children | Change from baseline at weeks 4, 6 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of bowel movements per week | Stool frequency per week | Change from baseline at weeks 4, 6 and 8 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy J Dahl, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida, Food Science and Human Nutrition Dept | Gainesville | Florida | 32611 | United States |
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| Control | Dietary Supplement | Baked goods (2 snacks) without added fiber |
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