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Efficacy of Pea Hull Fiber - Phase 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03016065
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : October 5, 2020
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
University of Florida

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 29, 2017
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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

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

Secondary Outcome Measures :
  1. Number of bowel movements per day averaged by week [ Time Frame: 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) [ Time Frame: Change from baseline at weeks 4, 6 and 8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 15 Years   (Child)
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03016065

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Contact: Wendy J Dahl, PhD 352 294 3707
Contact: Zainab Alyousif, MS 352 392 1991

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United States, Florida
University of Florida, Food Science and Human Nutrition Dept Recruiting
Gainesville, Florida, United States, 32611
Contact: Wendy J Dahl, PhD    352-392-1991 ext 224   
Principal Investigator: Wendy J Dahl, PhD         
Sponsors and Collaborators
University of Florida
Saskatchewan Pulse Growers
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Principal Investigator: Wendy J Dahl, PhD University of Florida
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Responsible Party: University of Florida Identifier: NCT03016065    
Other Study ID Numbers: IRB201602266
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No