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

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

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.

Study Overview

• Status: Completed
• Conditions: Food Selection
• Intervention / Treatment: Dietary supplement: Low FODMAP Oral Nutrition Supplement

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • St. Paul, Minnesota, United States, 55108
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low FODMAP Oral Nutrition Supplement 1; Low FODMAP Oral Nutrition Supplement	Dietary supplement: Low FODMAP Oral Nutrition Supplement
Experimental: Low FODMAP Oral Nutrition Supplement 2; Low FODMAP Oral Nutrition Supplement	Dietary supplement: Low FODMAP Oral Nutrition Supplement
Experimental: Low FODMAP Oral Nutrition Supplement 3; Low FODMAP Oral Nutrition Supplement	Dietary supplement: Low FODMAP Oral Nutrition Supplement
Experimental: FOS Supplement; Supplement containing fructooligosaccharides	Dietary supplement: Low FODMAP Oral Nutrition Supplement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota

Publications and helpful links

General Publications

• Erickson J, Korczak R, Wang Q, Slavin J. Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial. Nutr J. 2017 May 25;16(1):35. doi: 10.1186/s12937-017-0256-3.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1507E75043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO