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

Study Overview
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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.

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

Conditions
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Tolerance

Intervention / Treatment
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* Other: polydextrose
* Other: soluble corn fiber


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |