Trials / Completed
CompletedNCT05902806
Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults
Evaluation of the Gastro-intestinal Tolerance, Nutritional Intake, and Acceptability of an Upgraded Composition of an Enteral Tube Feed for Adults in Need of Long Term Nutritional Support (Peacock Butterfly)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Nutricia Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.
Detailed description
Four current tube feed products are upgraded with the same product composition and will be investigated in this study. Subjects will be asked to continue with their current tube feeding for 7 days (baseline period) and asked to complete a daily gastro-intestinal tolerance questionnaire. On Day 8, the subjects will switch to one of four upgraded tube feeding products for 14 days (intervention period). The subjects are asked to complete the same gastro-intestinal tolerance questionnaire for again 7 days. On Day 21 (end of intervention), the subjects will return to their original tube feed product and the investigator will follow up on how they are feeling to evaluate tolerability and product acceptability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Upgraded tube feed | Total duration of study: 4 weeks; 1 week on current tube feed followed by 2 weeks on upgraded tube feed comparable in energy density and fiber content as their current tube feed. The tube feeding regimen is similar to pre study feeding regimen. There will then be a one week follow up period. |
Timeline
- Start date
- 2023-05-23
- Primary completion
- 2024-02-05
- Completion
- 2024-02-05
- First posted
- 2023-06-15
- Last updated
- 2024-03-12
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05902806. Inclusion in this directory is not an endorsement.