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

Study Overview
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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 .

Official Title
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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

Conditions
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Enteral Nutrition

Intervention / Treatment
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* Dietary Supplement: low FODMAP
* Dietary Supplement: moderate FODMAP
* Dietary Supplement: high FODMAP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diarrhea |  | 14-day follow-up | 

Secondary Outcome Measures

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