Efficacy of Pea Hull Fiber - Phase 2

NCT ID: NCT03016065

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2022-11-15

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pea Fiber

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Baked goods (2 snacks) without added fiber

Interventions

Pea Fiber

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

Intervention Type: DIETARY_SUPPLEMENT

Control

Baked goods (2 snacks) without added fiber

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saskatchewan Pulse Growers

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy J Dahl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida, Food Science and Human Nutrition Dept

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201602266

Identifier Type: -

Identifier Source: org_study_id