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

NCT ID: NCT02091349

Last Updated: 2014-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A- placebo

control- snack bar or muffin containing no fiber

Group Type PLACEBO_COMPARATOR

polydextrose

Intervention Type OTHER

polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods

soluble corn fiber

Intervention Type OTHER

nutirose- 7, 14, or 21 grams/day

Group B- polydextrose

polydextrose- randomly bonded polysaccharide of glucose which is poorly digested in small intestine

Group Type EXPERIMENTAL

polydextrose

Intervention Type OTHER

polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods

soluble corn fiber

Intervention Type OTHER

nutirose- 7, 14, or 21 grams/day

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

Group Type EXPERIMENTAL

polydextrose

Intervention Type OTHER

polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods

soluble corn fiber

Intervention Type OTHER

nutirose- 7, 14, or 21 grams/day

Interventions

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polydextrose

polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods

Intervention Type OTHER

soluble corn fiber

nutirose- 7, 14, or 21 grams/day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Fahey, Jr, PhD

Role: PRINCIPAL_INVESTIGATOR

UIUC

References

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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.

Reference Type DERIVED
PMID: 25527750 (View on PubMed)

Other Identifiers

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09491

Identifier Type: -

Identifier Source: org_study_id

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