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OpenTrials
Completed

NCT Number: NCT02091349

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.

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Key information

Conditions

Tolerance

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polydextrose

Other

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

soluble corn fiber

Other

nutirose- 7, 14, or 21 grams/day

Primary outcomes

  1. Fecal bacteria

    Time frame: 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.

  2. Fecal fermentation end products

    Time frame: 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 outcomes

  1. Gastrointestinal Tolerance

    Time frame: 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.

  2. Daily Stool Characteristics

    Time frame: 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.

Other outcomes

  1. Daily food intake journals

    Time frame: Daily during each 21-day treatment period

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 19, 2014
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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