The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement
Phase 2
Completed
- Conditions
- Enteral Nutrition
- Interventions
- Dietary Supplement: low FODMAPDietary Supplement: moderate FODMAPDietary Supplement: high FODMAP
- Registration Number
- NCT02353689
- Lead Sponsor
- Oh Yoen Kim
- 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.
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low FODMAP group low FODMAP consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention moderate FODMAP group moderate FODMAP consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention high FODMAP group high FODMAP consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention
- Primary Outcome Measures
Name Time Method diarrhea 14-day follow-up
- Secondary Outcome Measures
Name Time Method prealbumin 14-day follow-up body mass index 14-day follow-up