Potato Fiber and Gastrointestinal Function: Phase 3

Gastrointestinal Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964599
• Other study ID #: 215-2011
• Status: Completed
• Phase: N/A
• First received: October 14, 2013
• Last updated: January 25, 2017
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: January 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gastrointestinal Symptoms
• Gastrointestinal Transit Time
• Stool Frequency

Intervention

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.
• 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.
• 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.
• Control

Locations

Country	Name	City	State
United States	University of Florida Food Science & Human Nutrition Dept	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Frequency	Change in stool frequency determined by the daily questionnaire	6 weeks
Secondary	Gastrointestinal transit time	Change in gastrointestinal transit time determined by the Bristol Stool Scale	6 weeks
Secondary	Gastrointestinal symptoms	Change in gastrointestinal symptoms determined by the daily questionnaire	6 weeks
Secondary	Microbial diversity	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.	6 weeks