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

Oh Yoen Kim84 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Enteral Nutrition

Interventions

low FODMAPDIETARY_SUPPLEMENT

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

moderate FODMAPDIETARY_SUPPLEMENT

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

high FODMAPDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

diarrhea

Time frame: 14-day follow-up

Secondary Outcomes

prealbumin

Time frame: 14-day follow-up

body mass index

Time frame: 14-day follow-up

Data from ClinicalTrials.gov

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