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Completed

NCT Number: NCT01964599

Potato Fiber and Gastrointestinal Function: Phase 3

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.

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Key information

Conditions

Gastrointestinal Symptoms Gastrointestinal Transit Time Stool Frequency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Food Science & Human Nutrition Dept

Gainesville, Florida, 32601, United States

About this study

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:

  • To determine the effect of potato fibers on stool frequency, gastrointestinal transit time and gastrointestinal symptoms.
  • To determine the effect of potato fibers on microbial diversity in healthy individuals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PF-RS

Dietary 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-RO1

Dietary 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-RO2

Dietary 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.

Control

Dietary Supplement

Primary outcomes

  1. Stool Frequency

    Time frame: 6 weeks

    Change in stool frequency determined by the daily questionnaire

Secondary outcomes

  1. Gastrointestinal transit time

    Time frame: 6 weeks

    Change in gastrointestinal transit time determined by the Bristol Stool Scale

  2. Gastrointestinal symptoms

    Time frame: 6 weeks

    Change in gastrointestinal symptoms determined by the daily questionnaire

  3. Microbial diversity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Potato Fiber and Gastrointestinal Function: Phase 3 (Grant #94521)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2013
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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