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Gut Health Response to Dietary Fiber

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Dietary Fiber

Treatments

Dietary Supplement: dietary fiber

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01321736
1103M96878

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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