Gut Health Response to Dietary Fiber

Not Applicable

Completed

• Conditions: Dietary Fiber

• Registration Number: NCT01321736
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-04
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Weight

• 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
• smoking
• 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
• currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
• known allergy or sensitivity to formula ingredients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Stool weight	5 day collection	5 day fecal collection on last 5 days of 14 day feeding trial

Secondary Outcome Measures

Name	Time	Method
fecal microbiota	day 14 of feeding trial	fecal sample on last day of feeding trial will be collected for microbiota analysis

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 St. Paul, Minnesota, United States