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

Not Applicable

Completed

• Conditions: Tolerance
• Interventions: Other: polydextrose; Other: soluble corn fiber

• Registration Number: NCT02091349
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief 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.

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 Timeline

• Study Start: 2010-07
• Primary Completion: 2011-01
• Study Completion: 2012-07
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A- placebo	polydextrose	control- snack bar or muffin containing no fiber
Group A- placebo	soluble corn fiber	control- snack bar or muffin containing no fiber
Group B- polydextrose	polydextrose	polydextrose- randomly bonded polysaccharide of glucose which is poorly digested in small intestine
Group B- polydextrose	soluble corn fiber	polydextrose- randomly bonded polysaccharide of glucose which is poorly digested in small intestine
Group C- soluble corn fiber	polydextrose	Soluble corn fiber made from corn starch and contains oligosaccharides with random glyucosyl bonds and may contain minor amounts of monosaccharides
Group C- soluble corn fiber	soluble corn fiber	Soluble corn fiber made from corn starch and contains oligosaccharides with random glyucosyl bonds and may contain minor amounts of monosaccharides

Primary Outcome Measures

Name	Time	Method
Fecal bacteria	Days 16-21 of each treatment period	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.
Fecal fermentation end products	Days 16-21 of each treatment period	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.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerance	Daily during each 21 day treatment period	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 Stool Characteristics	Daily during each 21 day treatment period	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.