Tolerance of a Calorically Dense Enteral Nutrition Formula

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02806427

Enrollment

Registered

2016-06-20

Start date

2016-06-30

Completion date

2017-03-11

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding

Brief summary

This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.

Interventions

OTHEREnteral Formula

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult aged \> 18 years * Admitted to Medical ICU with expected admission of ≥ 3 days * Established enteral access * Having obtained his/her or legal representative's informed consent.

Exclusion criteria

* Pregnant or lactating * Condition which contraindicates enteral feeding (i.e. intestinal obstruction) * Lack of enteral access * Parenteral nutrition * Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.) * Subject who in the Investigator's assessment cannot be expected to comply with study protocol * Currently participating in another conflicting clinical trial.

Design outcomes

Primary

Measure	Time frame
Daily percentage of caloric nutritional goal met	First 3 days in the ICU

Secondary

Measure	Time frame
Daily percentage of protein goal met	First 5 days in the ICU
Adverse events and serious adverse events	First 5 days in the ICU

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026