Efficacy of Pea Hull Fiber - Phase 2

NCT03016065 | Completed

• 1 other identifier: IRB201602266
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in number of bowel movements per week

  Change from baseline at weeks 4, 6 and 8

Study Arms (2)

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.

Dietary Supplement: Pea Fiber

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.

Dietary Supplement: Control

Interventions

Pea Fiber DIETARY_SUPPLEMENT

Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls

Pea Fiber

Control DIETARY_SUPPLEMENT

Baked goods (2 snacks) without added fiber

Control

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Florida: lead
• Saskatchewan Pulse Growers: collaborator

Study Sites (1)

University of Florida, Food Science and Human Nutrition Dept

Gainesville, Florida, 32611, United States

Location

Study Officials

• Wendy J Dahl, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: March 29, 2017
• Primary Completion: December 15, 2019
• Study Completion: November 15, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)