Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber

Tolerance Clinical Trial

Official title:

Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091349
• Other study ID #: 09491
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: May 13, 2014
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2014
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.

Description:

Soluble fibers have been shown to have many positive effects in humans, including laxation and maintaining gastrointestinal health. It is expected that feeding soluble fibers will decrease protein fermentative end=products while increasing carbohydrate fermenative end-products, and lead to a more beneficial microbial profile. Determination of the effects of nutriose and polydextrose when included as supplemental fiber in a human diet will give insights to its potential to maintain or improve gut health and highlight its use in the food industry.

The object of this study are first to determine the tolerance of soluble fibers polydextrose, inulin and nutriose when provided as supplemental fiber to an existing diet. The second objective is to determine the utilization of polydextrose and nutriose through analyses of fecal samples of fermentative end-products and shifts in microbial populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• have body mass index (BMI) between 18.5 and 31 kg/m2

• free of metabolic and gastrointestinal disease

Exclusion Criteria:

• BMI less than 18.5 or greater than 31 kg/m2

• presence of metabolic or gastrointestinal diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tolerance

Intervention

Other:
• polydextrose
polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods
• soluble corn fiber
nutirose- 7, 14, or 21 grams/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Daily food intake journals	Participants were provided a journal to record their daily food and beverage intake. Each week the participants met with a study personnel minutes to review the journal and turn it in.	Daily during each 21-day treatment period	No
Primary	Fecal bacteria	Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for analysis of bacterial species present.	Days 16-21 of each treatment period	No
Primary	Fecal fermentation end products	Fecal samples will be collected on days 16-21 of each treatment period. Participants were provided fecal collection materials (fecal hats, packs, and Ziploc bags). Within 15 minutes of defecation, participants will bring their fecal sample to the designated collection site then be processed by a team. Fecal specimens will be aliquoted into containers for fermentation end product analysis (short-chain fatty indoles, ammonia) and dry matter.	Days 16-21 of each treatment period	No
Secondary	Gastrointestinal Tolerance	Gastrointestinal tolerance was scored using the following scale: 1=absent, 2=mild, 3=moderate, 4=severe. All study participants booklets with daily tolerance questionnaires in them. The participants will complete the questionnaires on their own each day.	Daily during each 21 day treatment period	No
Secondary	Daily Stool Characteristics	Participants are provided a journal to complete on their own each day, a questionnaire about their stool characteristics. Participants were score the ease of stool passage using the following scale: 1=very easy, 2=easy, 3=neither easy nor difficult, 4=difficult, 5=very difficult.; Stool consistency was scored using the Bristol stool scale: 1=separate hard lumps, like nuts; 2=sausage-shaped but lumpy; 3=like a sausage cracks on surface; 4=Like a sausage or snake, smooth and soft; 5=soft blobs with clear-cut edges; 6=fluffy pieces with ragged edges, 7=watery, no solid pieces, entirely liquid.	Daily during each 21 day treatment period	No