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Completed

NCT Number: NCT01321736

Gut Health Response to Dietary Fiber

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.

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Key information

Conditions

Dietary Fiber

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary fiber

Dietary Supplement

mixture of fiber sources added to liquid nutrition product

Other names: mixed fibers include fructans, soluble fiber, and insoluble fiber

Primary outcomes

  1. Stool weight

    Time frame: 5 day collection

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

Secondary outcomes

  1. fecal microbiota

    Time frame: day 14 of feeding trial

    fecal sample on last day of feeding trial will be collected for microbiota analysis

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study title

Gut Health Response to a New Fiber Blend

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 23, 2011
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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