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

Oh Yoen Kim

Status and phase: Completed; Phase 3; Phase 2

Conditions: Enteral Nutrition

Treatments: Dietary Supplement: high FODMAP; Dietary Supplement: moderate FODMAP; Dietary Supplement: low FODMAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02353689

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

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 84 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 3 patient groups

low FODMAP group

Experimental group

Description:

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

Treatment:

Dietary Supplement: low FODMAP

moderate FODMAP group

Experimental group

Description:

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

Treatment:

Dietary Supplement: moderate FODMAP

high FODMAP group

Experimental group

Description:

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

Treatment:

Dietary Supplement: high FODMAP