Gut Health Response to a New Fiber Blend

University of Minnesota1 site in 1 country20 target enrollmentApril 2011

ConditionsDietary Fiber

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dietary Fiber
Sponsor: University of Minnesota
Enrollment: 20
Locations: 1
Primary Endpoint: Stool weight
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Dietary fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight.

Detailed Description

Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets is linked to lower stool weight. The objective of this study is to feed liquid diets, with and without added fiber, to healthy human subjects to determine if mixed fiber sources can normalize stool weight. Secondary objectives of the study include measurement of gut microbiota and stool chemistry with fiber addition.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•BMI between 23 - 29
•having obtained his/her informed consent
•willing and able to exclusively consume enteral diets for two 14 day periods
•willing and able to collect stool samples as instructed

Exclusion Criteria

•any disease
•use of medication except for contraceptive medication and certain OTC medications not affecting laxation
•excessive exercise (\> 2 hours per week)
•consumption of more than 20 grams of dietary fiber daily
•pregnancy or lactation
•use of laxatives
•use of antibiotics in past 6 months
•use of pre or probiotics supplements in the past 2 months
•use of probiotic foods in the past month
•subjects who cannot be expected to comply with the study procedures