NCT02778230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

May 12, 2016

Last Update Submit

April 3, 2019

Conditions

Healthy

Keywords

fibergastrointestinalmicrobiota

Outcome Measures

Primary Outcomes (1)

  • Stool consistency rating by Bristol Stool Form Scale

    Assesses estimated transit time.

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

Secondary Outcomes (4)

  • Number of bowel movements per day averaged by week

    Changes from baseline to week 4, 6, 8, and 10

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

    Changes from baseline to week 4, 6, 8, and 10

  • GSRS (Gastrointestinal Symptom Response Scale) score.

    Changes from baseline to week 4, 6, 8, and 10

  • SNAQ (Simplified Nutritional Appetite Questionnaire) score.

    Changes from baseline to week 4, 6, 8, and 10

Study Arms (2)

Pea Fiber

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.

Dietary Supplement: Pea Fiber

Control

OTHER

Two control snacks will be consumed each day for a period of two weeks.

Dietary Supplement: Control

Interventions

Pea FiberDIETARY_SUPPLEMENT

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

Pea Fiber
ControlDIETARY_SUPPLEMENT

Snacks (2 baked goods) without fiber fortification.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Science and Human Department

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Alyousif Z, Mendoza DR, Auger J, De Carvalho V, Amos S, Sims C, Dahl WJ. Gastrointestinal Tolerance and Microbiome Response to Snacks Fortified with Pea Hull Fiber: A Randomized Trial in Older Adults. Curr Dev Nutr. 2020 Jan 17;4(2):nzaa005. doi: 10.1093/cdn/nzaa005. eCollection 2020 Feb.

    PMID: 32025615DERIVED

Study Officials

  • Wendy J Dahl, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 19, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 27, 2018

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

US(1)