Potato Fiber and Gastrointestinal Function: Phase 3

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Symptoms; Stool Frequency; Gastrointestinal Transit Time
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: PF-RS; Dietary supplement: PF-RO1; Dietary supplement: PF-RO2

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32601
      • University of Florida Food Science & Human Nutrition Dept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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: Control; 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.
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: Control; 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.
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: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Frequency	Change in stool frequency determined by the daily questionnaire	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal transit time	Change in gastrointestinal transit time determined by the Bristol Stool Scale	6 weeks
Gastrointestinal symptoms	Change in gastrointestinal symptoms determined by the daily questionnaire	6 weeks
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

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: October 14, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Fiber; Gastrointestinal
• Other Study ID Numbers: 215-2011