NCT02667184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

January 15, 2016

Last Update Submit

January 30, 2017

Conditions

Food Selection

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (1)

  • Gastrointestinal tolerance

    48 hours

Study Arms (4)

Low FODMAP Oral Nutrition Supplement 1

EXPERIMENTAL

Low FODMAP Oral Nutrition Supplement

Dietary Supplement: Low FODMAP Oral Nutrition Supplement

Low FODMAP Oral Nutrition Supplement 2

EXPERIMENTAL

Low FODMAP Oral Nutrition Supplement

Dietary Supplement: Low FODMAP Oral Nutrition Supplement

Low FODMAP Oral Nutrition Supplement 3

EXPERIMENTAL

Low FODMAP Oral Nutrition Supplement

Dietary Supplement: Low FODMAP Oral Nutrition Supplement

FOS Supplement

EXPERIMENTAL

Supplement containing fructooligosaccharides

Dietary Supplement: Low FODMAP Oral Nutrition Supplement

Interventions

Low FODMAP Oral Nutrition SupplementDIETARY_SUPPLEMENT
FOS SupplementLow FODMAP Oral Nutrition Supplement 1Low FODMAP Oral Nutrition Supplement 2Low FODMAP Oral Nutrition Supplement 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

Related Publications (1)

  • 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.

    PMID: 28545589DERIVED

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Joanne Slavin, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 28, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)