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NCT Number: NCT02667184

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

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Key information

Conditions

Food Selection Behavior Feeding Behavior Food Preferences

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low FODMAP Oral Nutrition Supplement

Dietary Supplement

Primary outcomes

  1. Breath hydrogen response

    Time frame: baseline

    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.

  2. Breath hydrogen response

    Time frame: 60 minutes

    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.

  3. Breath hydrogen response

    Time frame: 120 minutes

    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.

  4. Breath hydrogen response

    Time frame: 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 outcomes

  1. Gastrointestinal tolerance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2016
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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