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

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ClinicalTrials.gov Identifier: NCT02353689
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 5, 2015
Sponsor:
Collaborator:
Dong-A University
Information provided by (Responsible Party):
Oh Yoen Kim, Dong-A University

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.

Condition or disease Intervention/treatment Phase
Enteral Nutrition Dietary Supplement: low FODMAP Dietary Supplement: moderate FODMAP Dietary Supplement: high FODMAP Phase 2 Phase 3

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: low FODMAP group
consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
Dietary Supplement: low FODMAP
consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention

Experimental: moderate FODMAP group
consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
Dietary Supplement: moderate FODMAP
consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention

Experimental: high FODMAP group
consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention
Dietary Supplement: high FODMAP
consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention




Primary Outcome Measures :
  1. diarrhea [ Time Frame: 14-day follow-up ]

Secondary Outcome Measures :
  1. prealbumin [ Time Frame: 14-day follow-up ]
  2. body mass index [ Time Frame: 14-day follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353689


Sponsors and Collaborators
Oh Yoen Kim
Dong-A University
Investigators
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Principal Investigator: Oh Yoen Kim, PhD Dong-A Univeristy
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Responsible Party: Oh Yoen Kim, Assistant Professor, Dong-A University
ClinicalTrials.gov Identifier: NCT02353689    
Other Study ID Numbers: 2-1040709-AB-N-01-201310-BR-03
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015