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Efficacy of Pea Hull Fiber - Phase 2

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ClinicalTrials.gov Identifier: NCT03016065
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Saskatchewan Pulse Growers
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE March 29, 2017
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Stool consistency rating by Modified Bristol Stool Form Scale for Children [ Time Frame: Change from baseline at weeks 4, 6 and 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • Number of bowel movements per day averaged by week [ Time Frame: Change from baseline at weeks 4, 6 and 8 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • Number of bowel movements per day averaged by week [ Time Frame: Change from baseline at weeks 4, 6 and 8 ]
  • Microbiota profile changes: percent change at phylum and genus levels; changes in OTUs [ Time Frame: Change from baseline at weeks 4, 6 and 8 ]
  • CSQ (Constipation Symptoms Questionnaire) score [ Time Frame: Change from baseline at weeks 4, 6 and 8 ]
  • Hunger score [ Time Frame: Change from baseline at weeks 4, 6 and 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Pea Hull Fiber - Phase 2
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Pea Fiber
    Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls
  • Dietary Supplement: Control
    Baked goods (2 snacks) without added fiber
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Pea Fiber
  • 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.
    Intervention: Dietary Supplement: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2017)
25
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wendy J Dahl, PhD 352 294 3707 wdahl@ufl.edu
Contact: Zainab Alyousif, MS 352 392 1991 zalyousif@ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03016065
Other Study ID Numbers  ICMJE IRB201602266
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Saskatchewan Pulse Growers
Investigators  ICMJE
Principal Investigator: Wendy J Dahl, PhD University of Florida
PRS Account University of Florida
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP