NCT02091349

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

March 17, 2014

Last Update Submit

May 13, 2014

Conditions

Tolerance

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Gastrointestinal Tolerance

    Daily during each 21 day treatment period

  • Daily Stool Characteristics

    Daily during each 21 day treatment period

Other Outcomes (1)

  • Daily food intake journals

    Daily during each 21-day treatment period

Study Arms (3)

Group A- placebo

PLACEBO COMPARATOR

control- snack bar or muffin containing no fiber

Other: polydextroseOther: soluble corn fiber

Group B- polydextrose

EXPERIMENTAL

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

Other: polydextroseOther: soluble corn fiber

Group C- soluble corn fiber

EXPERIMENTAL

Soluble corn fiber made from corn starch and contains oligosaccharides with random glyucosyl bonds and may contain minor amounts of monosaccharides

Other: polydextroseOther: soluble corn fiber

Interventions

polydextroseOTHER

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

Group A- placeboGroup B- polydextroseGroup C- soluble corn fiber
soluble corn fiberOTHER

nutirose- 7, 14, or 21 grams/day

Group A- placeboGroup B- polydextroseGroup C- soluble corn fiber

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • have body mass index (BMI) between 18.5 and 31 kg/m2
  • free of metabolic and gastrointestinal disease

You may not qualify if:

  • BMI less than 18.5 or greater than 31 kg/m2
  • presence of metabolic or gastrointestinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25527750DERIVED

MeSH Terms

Interventions

polydextrose

Study Officials

  • George Fahey, Jr, PhD

    UIUC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 19, 2014

Study Start

July 1, 2010

Primary Completion

January 1, 2011

Study Completion

July 1, 2012

Last Updated

May 14, 2014

Record last verified: 2014-05