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Completed

NCT Number: NCT02778230

Efficacy of Pea Hull Fibre Supplementation

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Science and Human Department

Gainesville, Florida, 32611, United States

About this study

A 10-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, gastrointestinal symptoms, stool frequency, and stool consistency (transit time) will be collected by paper questionnaire, and participants will collect a single stool. Dietary data (24-hour dietary recalls) will be obtained via phone interviews 3 times during the baseline period. On or about day 15, participants will attend a study visit and complete the Simplified Nutritional Appetite Questionnaire (SNAQ) and Gastrointestinal Symptom Response Scale (GSRS). 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 appetite, gastrointestinal symptoms, and stool frequency and consistency (transit time). Furthermore, they will complete SNAQ and GSRS after the end of each intervention period. The 24-hour dietary recalls will also be collected 3 times during each of the intervention periods. Participants will undergo an additional 2-week washout period after the second intervention period. During washout periods, the same data will be collected as was done during the baseline and intervention periods.Participants will be asked to collect one stool during pre-baseline and weeks 4, 6, 8 and 10 for a total of 5 stools. Stool samples will be analyzed for changes in the microbiota.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
  • Willing to consume pea hull fiber and control snacks daily each for a 2-week period
  • Willing to complete a daily questionnaire regarding general and gastrointestinal wellness throughout the entire 10-weeks study.
  • Willing to complete the GSRS (Gastrointestinal Symptom Rating Scale) and SNAQ questionnaires bi-weekly at study appointments.
  • Willing to be interviewed for a 24-hr food recall, 3 times per 2-weeks period throughout the study.
  • Willing to provide 5 stool samples, one in each 2-weeks period throughout the study.
  • 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.
  • 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 diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).

Treatment and study plan

Pea Fiber

Dietary Supplement

Snacks (2 baked goods) fortified with 5 g pea hull fiber

Control

Dietary Supplement

Snacks (2 baked goods) without fiber fortification.

Primary outcomes

  1. Stool consistency rating by Bristol Stool Form Scale

    Time frame: Changes from baseline to week 4, 6, 8 and 10.

    Assesses estimated transit time.

Secondary outcomes

  1. Number of bowel movements per day averaged by week

    Time frame: Changes from baseline to week 4, 6, 8, and 10

    stool frequency

  2. Microbiota profile changes: percent change at phylum and genus levels; changes in OTUs

    Time frame: Changes from baseline to week 4, 6, 8, and 10

  3. GSRS (Gastrointestinal Symptom Response Scale) score.

    Time frame: Changes from baseline to week 4, 6, 8, and 10

  4. SNAQ (Simplified Nutritional Appetite Questionnaire) score.

    Time frame: Changes from baseline to week 4, 6, 8, and 10

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Saskatchewan Pulse Growers

Registry information

Official study title

Efficacy of Pea Hull Fibre Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Older Adults.

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 19, 2016
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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