Potato Fiber and Gastrointestinal Function: Phase 3

University of Florida

Status: Completed

Conditions: Stool Frequency; Gastrointestinal Symptoms; Gastrointestinal Transit Time

Treatments: Dietary Supplement: PF-RO2; Dietary Supplement: Control; Dietary Supplement: PF-RS; Dietary Supplement: PF-RO1

Study type: Interventional

Funder types: Other

Identifiers

NCT01964599

215-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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90 participants in 3 patient groups

PF-RS

Other group

Description:

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

Treatment:

Dietary Supplement: Control

Dietary Supplement: PF-RS

PF-RO1

Other group

Description:

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

Treatment:

Dietary Supplement: Control

Dietary Supplement: PF-RO1

PF-RO2

Other group

Description:

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

Treatment:

Dietary Supplement: PF-RO2

Dietary Supplement: Control