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

NCT ID: NCT02353689

Last Updated: 2015-02-05

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

PHASE2/PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Enteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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low FODMAP group

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

Group Type EXPERIMENTAL

low FODMAP

Intervention Type DIETARY_SUPPLEMENT

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

moderate FODMAP group

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

Group Type EXPERIMENTAL

moderate FODMAP

Intervention Type DIETARY_SUPPLEMENT

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

high FODMAP group

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

Group Type EXPERIMENTAL

high FODMAP

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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low FODMAP

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

Intervention Type DIETARY_SUPPLEMENT

moderate FODMAP

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

Intervention Type DIETARY_SUPPLEMENT

high FODMAP

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A University

OTHER

Sponsor Role collaborator

Oh Yoen Kim

OTHER

Sponsor Role lead

Responsible Party

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Oh Yoen Kim

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Oh Yoen Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Dong-A Univeristy

Other Identifiers

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2-1040709-AB-N-01-201310-BR-03

Identifier Type: -

Identifier Source: org_study_id

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