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

NCT ID: NCT02667184

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Food Selection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low FODMAP Oral Nutrition Supplement 1

Low FODMAP Oral Nutrition Supplement

Group Type EXPERIMENTAL

Low FODMAP Oral Nutrition Supplement

Intervention Type DIETARY_SUPPLEMENT

Low FODMAP Oral Nutrition Supplement 2

Low FODMAP Oral Nutrition Supplement

Group Type EXPERIMENTAL

Low FODMAP Oral Nutrition Supplement

Intervention Type DIETARY_SUPPLEMENT

Low FODMAP Oral Nutrition Supplement 3

Low FODMAP Oral Nutrition Supplement

Group Type EXPERIMENTAL

Low FODMAP Oral Nutrition Supplement

Intervention Type DIETARY_SUPPLEMENT

FOS Supplement

Supplement containing fructooligosaccharides

Group Type EXPERIMENTAL

Low FODMAP Oral Nutrition Supplement

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Low FODMAP Oral Nutrition Supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Slavin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28545589 (View on PubMed)

Other Identifiers

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1507E75043

Identifier Type: -

Identifier Source: org_study_id

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