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

Not Applicable

Completed

• Conditions: Food Selection
• Interventions: Dietary Supplement: Low FODMAP Oral Nutrition Supplement

• Registration Number: NCT02667184
• Lead Sponsor: University of Minnesota

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2016-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FOS Supplement	Low FODMAP Oral Nutrition Supplement	Supplement containing fructooligosaccharides
Low FODMAP Oral Nutrition Supplement 1	Low FODMAP Oral Nutrition Supplement	Low FODMAP Oral Nutrition Supplement
Low FODMAP Oral Nutrition Supplement 3	Low FODMAP Oral Nutrition Supplement	Low FODMAP Oral Nutrition Supplement
Low FODMAP Oral Nutrition Supplement 2	Low FODMAP Oral Nutrition Supplement	Low FODMAP Oral Nutrition Supplement

Primary Outcome Measures

Name	Time	Method
Breath hydrogen response	240 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	48 hours	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 St. Paul, Minnesota, United States