Efficacy of Pea Hull Fibre Supplementation | NCT02778230

Studies
Efficacy of Pea Hull Fibre Supplementation

NCT02778230

Sponsor

University of Florida

Status

Completed

Last Update Posted

Apr 5, 2019Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Pea Fiber
Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Dec 27, 2018Actual

First Submitted Date

May 12, 2016

First Submission Date that Met QC Criteria

May 17, 2016

First Posted Date

May 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2019

Last Update Posted Date

Apr 5, 2019Actual

Name	Class
Saskatchewan Pulse Growers	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pea Fiber	Dietary Supplement	Snacks (2 baked goods) fortified with 5 g pea hull fiber	Pea Fiber

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool consistency rating by Bristol Stool Form Scale	Assesses estimated transit time.	Changes from baseline to week 4, 6, 8 and 10.

Secondary Outcomes

Measure	Description	Time Frame
Number of bowel movements per day averaged by week	stool frequency	Changes from baseline to week 4, 6, 8, and 10
Microbiota profile changes: percent change at phylum and genus levels; changes in OTUs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Wendy J Dahl, PhD	University of Florida	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Food Science and Human Department		Gainesville	Florida	32611	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32025615	Derived	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.