Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula

Prospective Study of Ability to Meet Nutritional Needs with a Peptide-based, High Protein Enteral Formula

This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.

Study Overview

• Status: Completed
• Conditions: Enteral Feeding
• Intervention / Treatment: Other: Medical Food: Peptide-Based Enteral Formula

Detailed Description

This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults with established enteral access
• Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
• Signed informed consent

Exclusion Criteria:

• Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
• Any condition that would contraindicate use of the study product
• Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment
• Judged to be at risk for poor compliance to the study protocol
• Participating in a conflicting clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Enteral Tube-fed Adults; Adults being fed an enteral formula with a feeding tube	Other: Medical Food: Peptide-Based Enteral Formula; Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calorie nutritional goals	Daily percentage of calorie nutritional goals met	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein nutritional goals	Daily percentage of protein nutritional goals met	14 days
Daily reports of gastrointestinal intolerance	Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting)	14 days
Adverse events	Daily adverse event reporting	14 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Study Director: Krysmaru Araujo Torres, MD, Nestle Health Science

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 19.01.CA.HCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No