Skip to content

Gut Health Response to Dietary Fiber

Gut Health Response to a New Fiber Blend

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01321736
Enrollment
20
Registered
2011-03-23
Start date
2011-04-30
Completion date
2012-12-31
Last updated
2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Fiber

Keywords

dietary fiber, enteral nutrition, laxation

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.

Interventions

DIETARY_SUPPLEMENTdietary fiber

mixture of fiber sources added to liquid nutrition product

Sponsors

Société des Produits Nestlé (SPN)
CollaboratorINDUSTRY
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Stool weight5 day collection5 day fecal collection on last 5 days of 14 day feeding trial

Secondary

MeasureTime frameDescription
fecal microbiotaday 14 of feeding trialfecal sample on last day of feeding trial will be collected for microbiota analysis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026