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

Food Selection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667184
• Other study ID #: 1507E75043
• Status: Completed
• Phase: N/A
• First received: January 15, 2016
• Last updated: January 30, 2017
• Start date: May 2016
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Selection

Intervention

Dietary Supplement:
• Low FODMAP Oral Nutrition Supplement

Locations

Country	Name	City	State
United States	University of Minnesota	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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