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

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.

Study Overview

• Status: Completed
• Conditions: Tolerance
• Intervention / Treatment: Other: polydextrose; Other: soluble corn fiber

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A- placebo; control- snack bar or muffin containing no fiber	Other: polydextrose; polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods; Other: soluble corn fiber; nutirose- 7, 14, or 21 grams/day
Experimental: Group B- polydextrose; polydextrose- randomly bonded polysaccharide of glucose which is poorly digested in small intestine	Other: polydextrose; polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods; Other: soluble corn fiber; nutirose- 7, 14, or 21 grams/day
Experimental: Group C- soluble corn fiber; Soluble corn fiber made from corn starch and contains oligosaccharides with random glyucosyl bonds and may contain minor amounts of monosaccharides	Other: polydextrose; polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods; Other: soluble corn fiber; nutirose- 7, 14, or 21 grams/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: George Fahey, Jr, PhD, UIUC

Publications and helpful links

General Publications

• Holscher HD, Caporaso JG, Hooda S, Brulc JM, Fahey GC Jr, Swanson KS. Fiber supplementation influences phylogenetic structure and functional capacity of the human intestinal microbiome: follow-up of a randomized controlled trial. Am J Clin Nutr. 2015 Jan;101(1):55-64. doi: 10.3945/ajcn.114.092064. Epub 2014 Nov 12.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 09491