NCT02353689

Brief Summary

This study aimed to investigate the effects of FODMAP contents in enteral nutrition (EN) formulas on major gastrointestinal intolerance symptoms and nutritional status in tube fed patients through the randomized, double blind and placebo-controlled trial.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

January 29, 2015

Last Update Submit

February 4, 2015

Conditions

Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • diarrhea

    14-day follow-up

Secondary Outcomes (2)

  • prealbumin

    14-day follow-up

  • body mass index

    14-day follow-up

Study Arms (3)

low FODMAP group

EXPERIMENTAL

consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention

Dietary Supplement: low FODMAP

moderate FODMAP group

EXPERIMENTAL

consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention

Dietary Supplement: moderate FODMAP

high FODMAP group

EXPERIMENTAL

consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention

Dietary Supplement: high FODMAP

Interventions

low FODMAPDIETARY_SUPPLEMENT

consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention

low FODMAP group
moderate FODMAPDIETARY_SUPPLEMENT

consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention

moderate FODMAP group
high FODMAPDIETARY_SUPPLEMENT

consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention

high FODMAP group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • tube-feeding patients

You may not qualify if:

  • EN prohibited
  • renal dysfunction (i.e. serum creatinine \> 1.5 mg/dl or blood urea nitrogen \> 25 mg/ml)
  • liver dysfunction (i.e. serum aspartate aminotransferase \> 40 U/L or alanine aminotransferase \> 40 U/L)
  • uncontrollable diabetes mellitus
  • pregnancy, breast-feeding etc.
  • severe diarrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

FODMAP Diet

Intervention Hierarchy (Ancestors)

Elimination DietsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Oh Yoen Kim, PhD

    Dong-A Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 3, 2015

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02