Potato Fiber and Gastrointestinal Function: Phase 3

NCT ID: NCT01964599

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Symptoms Gastrointestinal Transit Time Stool Frequency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-RS

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

Group Type OTHER

PF-RS

Intervention Type 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.

Control

Intervention Type DIETARY_SUPPLEMENT

PF-RO1

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

Group Type OTHER

PF-RO1

Intervention Type 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.

Control

Intervention Type DIETARY_SUPPLEMENT

PF-RO2

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

Group Type OTHER

PF-RO2

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Control

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wendy J Dahl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida Food Science & Human Nutrition Dept

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

215-2011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Resistant Potato Starch to Alleviate GWI
NCT05820893 RECRUITING PHASE2