NCT01964599

Brief Summary

The primary physiological impacts of fiber intake include the gastrointestinal effects of stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT). Fermentation of resistant starches by microbiota increases bacterial numbers, which increases fecal bulk and may impact frequency and transit time. The purpose of this study is to determine the effects of resistant potato starches (potato fiber) on stool frequency, transit time and microbiota in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

October 14, 2013

Last Update Submit

January 25, 2017

Conditions

Gastrointestinal SymptomsGastrointestinal Transit TimeStool Frequency

Keywords

FiberGastrointestinal

Outcome Measures

Primary Outcomes (1)

  • Stool Frequency

    Change in stool frequency determined by the daily questionnaire

    6 weeks

Secondary Outcomes (3)

  • Gastrointestinal transit time

    6 weeks

  • Gastrointestinal symptoms

    6 weeks

  • Microbial diversity

    6 weeks

Study Arms (3)

PF-RS

OTHER

14 days consuming the PF-RS containing 30 g fiber and then 14 days consuming the control containing no fiber

Dietary Supplement: PF-RSDietary Supplement: Control

PF-RO1

OTHER

14 days consuming the PF-RO1 containing 30 g fiber and then 14 days consuming the control containing no fiber

Dietary Supplement: PF-RO1Dietary Supplement: Control

PF-RO2

OTHER

14 days consuming the PF-RO2 containing 30 g fiber and then 14 days consuming the control containing no fiber

Dietary Supplement: PF-RO2Dietary Supplement: Control

Interventions

PF-RSDIETARY_SUPPLEMENT

n=20 will consume PF-RS containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.

PF-RS
PF-RO1DIETARY_SUPPLEMENT

n=20 will consume PF-RO1 containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.

PF-RO1
PF-RO2DIETARY_SUPPLEMENT

n=20 will consume PF-RO2 containing 30 g potato fiber for 14 days and then will consume a control containing no fiber for 14 days.

PF-RO2
ControlDIETARY_SUPPLEMENT
PF-RO1PF-RO2PF-RS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be between the ages of 18 and 65.
  • must be willing to complete daily questionnaires.
  • must be willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
  • must have internet access for the duration of the study
  • must have usual fiber intake of \<20 g/d based on Food Frequency Questionnaire such as the Block Fruit/Vegetable/Fiber Screener
  • must be willing to consume kool-aid everyday for 2 periods of 14 days
  • must be willing to provide stool samples

You may not qualify if:

  • must not have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
  • must not have a food allergy
  • must not take dietary supplements (prebiotic and fiber supplements)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Food Science & Human Nutrition Dept

Gainesville, Florida, 32601, United States

Location

Study Officials

  • Wendy J Dahl, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 17, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

US(1)