Gut Health Response to Dietary Fiber
Gut Health Response to a New Fiber Blend
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 6, 2013
December 1, 2013
1.1 years
March 22, 2011
December 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stool weight
5 day fecal collection on last 5 days of 14 day feeding trial
5 day collection
Secondary Outcomes (1)
fecal microbiota
day 14 of feeding trial
Interventions
mixture of fiber sources added to liquid nutrition product
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- Société des Produits Nestlé (SPN)collaborator
Study Sites (1)
University of Minnesota
Saint Paul, Minnesota, 55108, United States
Related Publications (1)
Koecher KJ, Thomas W, Slavin JL. Healthy subjects experience bowel changes on enteral diets: addition of a fiber blend attenuates stool weight and gut bacteria decreases without changes in gas. JPEN J Parenter Enteral Nutr. 2015 Mar;39(3):337-43. doi: 10.1177/0148607113510523. Epub 2013 Nov 14.
PMID: 24233256DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Slavin, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
March 23, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2012
Study Completion
December 1, 2012
Last Updated
December 6, 2013
Record last verified: 2013-12