The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Healthy Human Subjects

Study Overview
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Brief Summary
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The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over a 4 hour time period.

Detailed Description
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This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen and methane analysis at various time points over a 4 hour time period. Subjects will also be asked to rate gastrointestinal symptoms via a questionnaire at various time points throughout the study.

Official Title
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The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Health Human Subjects

Conditions
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Food Selection

Intervention / Treatment
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* Dietary Supplement: Low FODMAP Oral Nutrition Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18-65 years with a body mass index between 18-29 kg/m2. Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures. Exclusion Criteria: Use of enemas, proton pump inhibitors, or antibiotics within the past 3 months Smoker Not a regular breakfast eater Self-reported history of a past or current gastrointestinal disease High fiber eater (> or = to 3 servings of high fiber foods per day) Concurrent or recent (within 30 days) participation in an intervention trial Recent weight fluctuations Allergies to any of the test products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low FODMAP Oral Nutrition Supplement 1<br>Low FODMAP Oral Nutrition Supplement | Dietary Supplement: Low FODMAP Oral Nutrition Supplement<br> <br> |
| Experimental: Low FODMAP Oral Nutrition Supplement 2<br>Low FODMAP Oral Nutrition Supplement | Dietary Supplement: Low FODMAP Oral Nutrition Supplement<br> <br> |
| Experimental: Low FODMAP Oral Nutrition Supplement 3<br>Low FODMAP Oral Nutrition Supplement | Dietary Supplement: Low FODMAP Oral Nutrition Supplement<br> <br> |
| Experimental: FOS Supplement<br>Supplement containing fructooligosaccharides | Dietary Supplement: Low FODMAP Oral Nutrition Supplement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath hydrogen response | At baseline, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon. | baseline | 
| Breath hydrogen response | At 60 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon. | 60 minutes | 
| Breath hydrogen response | At 120 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation. | 120 minutes | 
| Breath hydrogen response | At 240 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation. | 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Subjects will answer a 7 symptom questionnaire regarding the intensity of gastrointestinal symptoms experienced following consumption of each of the supplements. Questionnaire is adapted from the validated Bovenshen gastrointestinal tolerance questionnaire. Questionnaire is to be completed at baseline, 30 min, 60 min, 90 min, 120 min, 180 min, 12 hours, 24 and 48 hours. | 48 hours |