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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low FODMAP Oral Nutrition Supplement 1 | Experimental | Low FODMAP Oral Nutrition Supplement |
|
| Low FODMAP Oral Nutrition Supplement 2 | Experimental | Low FODMAP Oral Nutrition Supplement |
|
| Low FODMAP Oral Nutrition Supplement 3 | Experimental | Low FODMAP Oral Nutrition Supplement |
|
| FOS Supplement | Experimental | Supplement containing fructooligosaccharides |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low FODMAP Oral Nutrition Supplement | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Slavin, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Saint Paul | Minnesota | 55108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28545589 | Derived | Erickson J, Korczak R, Wang Q, Slavin J. Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial. Nutr J. 2017 May 25;16(1):35. doi: 10.1186/s12937-017-0256-3. |
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| ID | Term |
|---|---|
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 48 hours |