Efficacy of Pea Hull Fiber - Phase 2

• Sponsor: University of Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03016065
• Collaborator: Saskatchewan Pulse Growers (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 68.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Pea Fiber; Dietary Supplement: Control	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Efficacy of Pea Hull Fiber Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Older Adults, Individuals With Lifestyle-related Chronic Disease and Overweight Children. (Phase 2 - Overweight Children)
• Actual Study Start Date: Mar 29, 2017
• Anticipated Primary Completion Date: Dec 15, 2022
• Anticipated Study Completion Date: Dec 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Stool consistency rating by Modified Bristol Stool Form Scale for Children [Change from baseline at weeks 4, 6 and 8]

Secondary Outcome Measures

1. Number of bowel movements per day averaged by week [Change from baseline at weeks 4, 6 and 8]

2. Microbiota profile changes: percent change at phylum and genus levels; changes in operational taxonomic units (OTUs) [Change from baseline at weeks 4, 6 and 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida, Food Science and Human Nutrition Dept	Gainesville	Florida	United States	32611

Sponsors and Collaborators

• University of Florida
• Saskatchewan Pulse Growers

Investigators

• Principal Investigator: Wendy J Dahl, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03016065
• Other Study ID Numbers: IRB201602266
• First Posted: Jan 10, 2017
• Last Update Posted: Mar 24, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 24, 2022