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

Completed · Not applicable

Conditions studied: Food Selection

In brief

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.

Key facts

Study ID

NCT02667184

Run by

University of Minnesota

People needed

21

Starts

2016-05-01

Expected to finish

2016-06-01

Last updated by the study team

2017-01-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Minnesota — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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