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Potato Fiber and Gastrointestinal Function: Phase 3

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01964599
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
3
Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: PF-RS
  • Dietary Supplement: PF-RO1
  • Dietary Supplement: PF-RO2
  • Dietary Supplement: Control
 N/A

Detailed Description

Potato fiber (PF-RS, PF-RO1 and PF-RO2), supplemented in the diet of healthy individuals (n=60; 20 per group) and providing 30 g per day of fiber, will result in a significant changes in gastrointestinal function and microbiota profile.

Objectives:

  1. To determine the effect of potato fibers on stool frequency, gastrointestinal transit time and gastrointestinal symptoms.

  2. To determine the effect of potato fibers on microbial diversity in healthy individuals.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Potato Fiber and Gastrointestinal Function: Phase 3 (Grant #94521)
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: PF-RS

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

Dietary Supplement: PF-RS
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.

Dietary Supplement: Control
Other: PF-RO1

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

Dietary Supplement: PF-RO1
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.

Dietary Supplement: Control
Other: PF-RO2

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

Dietary Supplement: PF-RO2
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.

Dietary Supplement: Control

Outcome Measures

Primary Outcome Measures

  1. Stool Frequency [6 weeks]

    Change in stool frequency determined by the daily questionnaire

Secondary Outcome Measures

  1. Gastrointestinal transit time [6 weeks]

    Change in gastrointestinal transit time determined by the Bristol Stool Scale

  2. Gastrointestinal symptoms [6 weeks]

    Change in gastrointestinal symptoms determined by the daily questionnaire

  3. Microbial diversity [6 weeks]

    Baseline, treatment, control and washout stools (for a total of 6 samples) for each subject will be sampled for DNA isolation for microbiota studies. Microbial diversity measured by DGGE profiling (detects large distortions), qPCR to quantify changes and 16S rRNA sequencing (454) to identify treatment effects on specific bacteria (discovery) will be undertaken.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida Food Science & Human Nutrition Dept Gainesville Florida United States 32601

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Wendy J Dahl, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT01964599
Other Study ID Numbers:
  • 215-2011
First Posted:
Oct 17, 2013
Last Update Posted:
Jan 26, 2017
Last Verified:
Jan 1, 2017
Keywords provided by University of Florida
Fiber
Gastrointestinal

Study Results

No Results Posted as of Jan 26, 2017