The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement

February 4, 2015 updated by: Oh Yoen Kim

Identification of the Effect of Fermentable Oligo-, di-, and Mono- Saccharides and Poorly Absorbed Short-chain Carbohydrate (FODMAP) Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-blind, placebo-controlled study was conducted on 100 tube-fed patients. Over a 14-day test period, the test group consumed EN formula containing low FODMAPs, while the placebo groups consumed EN formula containing moderate or high FODMAPs .

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • tube-feeding patients

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low FODMAP group
consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
Dietary supplement: low FODMAP
consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
Experimental: moderate FODMAP group
consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
Dietary supplement: moderate FODMAP
consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
Experimental: high FODMAP group
consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention
Dietary supplement: high FODMAP
consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diarrhea
Time Frame: 14-day follow-up
14-day follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
prealbumin
Time Frame: 14-day follow-up
14-day follow-up
body mass index
Time Frame: 14-day follow-up
14-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oh Yoen Kim

Collaborators

Dong-A University

Investigators

  • Principal Investigator: Oh Yoen Kim, PhD, Dong-A Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2-1040709-AB-N-01-201310-BR-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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