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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Food Selection

Treatments

Dietary Supplement: Low FODMAP Oral Nutrition Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT02667184
1507E75043

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

21 participants in 4 patient groups

Low FODMAP Oral Nutrition Supplement 1
Experimental group
Description:
Low FODMAP Oral Nutrition Supplement
Treatment:
Dietary Supplement: Low FODMAP Oral Nutrition Supplement
Low FODMAP Oral Nutrition Supplement 2
Experimental group
Description:
Low FODMAP Oral Nutrition Supplement
Treatment:
Dietary Supplement: Low FODMAP Oral Nutrition Supplement
Low FODMAP Oral Nutrition Supplement 3
Experimental group
Description:
Low FODMAP Oral Nutrition Supplement
Treatment:
Dietary Supplement: Low FODMAP Oral Nutrition Supplement
FOS Supplement
Experimental group
Description:
Supplement containing fructooligosaccharides
Treatment:
Dietary Supplement: Low FODMAP Oral Nutrition Supplement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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