Overview

This trial is active, not recruiting.

Condition healthy
Treatments pea fiber, control
Sponsor University of Florida
Collaborator Saskatchewan Pulse Growers
Start date June 2016
End date November 2016
Trial size 22 participants
Trial identifier NCT02778230, IRB201600646

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Two fiber snacks fortified with 5 g/each of pea fiber (Best Pea Fiber 200) will be consumed each day for a period of two weeks.
pea fiber
Snacks (2 baked goods) fortified with 5 g pea hull fiber
(Other)
Two control snacks will be consumed each day for a period of two weeks.
control
Snacks (2 baked goods) without fiber fortification.

Primary Outcomes

Measure
Stool consistency rating by Bristol Stool Form Scale
time frame: Changes from baseline to week 4, 6, 8 and 10.

Secondary Outcomes

Measure
Number of bowel movements per day averaged by week
time frame: Changes from baseline to week 4, 6, 8, and 10
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
GSRS (Gastrointestinal Symptom Response Scale) score.
time frame: Changes from baseline to week 4, 6, 8, and 10
SNAQ (Simplified Nutritional Appetite Questionnaire) score.
time frame: Changes from baseline to week 4, 6, 8, and 10

Eligibility Criteria

Male or female participants at least 60 years old.

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.).

Additional Information

Official title Efficacy of Pea Hull Fibre Supplementation on Gastrointestinal Transit Time-induced Reduction in Proteolytic Fermentation and Enhancement of Wellness in Older Adults.
Principal investigator Wendy J Dahl, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Florida.