Gut Health Response to Dietary Fiber

Dietary Fiber Clinical Trial

Official title:

Gut Health Response to a New Fiber Blend

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321736
• Other study ID #: 1103M96878
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: December 5, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dietary Fiber

Intervention

Dietary Supplement:
• dietary fiber
mixture of fiber sources added to liquid nutrition product

Locations

Country	Name	City	State
United States	University of Minnesota	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool weight	5 day fecal collection on last 5 days of 14 day feeding trial	5 day collection	No
Secondary	fecal microbiota	fecal sample on last day of feeding trial will be collected for microbiota analysis	day 14 of feeding trial	No