Food Selection
Conditions
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTLow FODMAP Oral Nutrition Supplement
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath hydrogen response | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance | 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. |
Countries
United States
Outcome results
None listed