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Clinical Trials/NCT01321736
NCT01321736CompletedNot Applicable

Gut Health Response to a New Fiber Blend

University of Minnesota1 site in 1 country20 target enrollmentStarted: April 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Stool weight
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •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

Outcomes

Primary Outcomes

Stool weight

Time Frame: 5 day collection

5 day fecal collection on last 5 days of 14 day feeding trial

Secondary Outcomes

  • fecal microbiota(day 14 of feeding trial)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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