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

University of Minnesota21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Food Selection

Interventions

Low FODMAP Oral Nutrition SupplementDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 240 minutes

Secondary Outcomes

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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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