Efficacy of Pea Hull Fiber - Phase 2

Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit in 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Pea Fiber; Dietary supplement: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida, Food Science and Human Nutrition Dept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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-week 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.

Exclusion criteria:

• 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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pea Fiber; 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; Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls
PLACEBO_COMPARATOR: Control; 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) without added fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Saskatchewan Pulse Growers

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2017
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): November 15, 2022

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (ESTIMATE): January 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB201602266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No