Efficacy of Pea Hull Fiber - Phase 2



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:8 - 15
Updated:11/28/2018
Start Date:March 29, 2017
End Date:December 2019
Contact:Wendy J Dahl, PhD
Email:wdahl@ufl.edu
Phone:352 294 3707

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Efficacy of Pea Hull Fiber Supplementation: Phase 2 - Overweight Children

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.

Potential participants will be included if they:

- Are willing to have height and weight measured and provide demographic information
(e.g. age, race, sex).

- Children age between 8-15 years old.

- Are occasionally constipated.

- Are willing to consume pea hull fiber and control snacks daily each for a 2-week
period

- Are willing to complete a daily questionnaire throughout the entire 8-weeks study.

- Are willing to complete the appetite questionnaire two times per week.

- Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) bi-weekly.

- Are willing to be interviewed for Automated Self-Administered 24-Hour-Kids-2014
(ASA24-Kids-2014) one time per 2-week period throughout the study.

- Are willing and be able to provide a valid social security for study payment purposes.

Potential participants will be excluded if they:

- Have any known food allergies.

- Are currently taking medications for diarrhea.

- Have taken antibiotics within the past four weeks prior to randomization.

- Have ≥ 6 bowel movements per week

- Are currently taking probiotics supplements and do not want to discontinue a minimum
of two weeks prior to the study.

- Have previously or are currently being treated for any gastrointestinal diseases such
as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
We found this trial at
1
site
Gainesville, Florida 32601
Principal Investigator: Wendy J Dahl, PhD
Phone: 352-392-1991
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mi
from
Gainesville, FL
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