Nutritional Tolerance and Safety of a Tube Feeding Formula

A Single-Center, Open-Label Study on the Nutritional Adequacy, Tolerability, and Safety of a Standard Tube Feeding Formula in Adult Participants

This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, enteral formula in medically stable adults, who currently require or will require to be enterally fed.

Study Overview

• Status: Terminated
• Conditions: Enteral Feeding
• Intervention / Treatment: Other: Compleat 1.5

Detailed Description

In patients unable to meet energy and protein requirements orally, enteral nutrition (EN) often serves as the sole source of nutrition for long-term tube fed individuals in varied care settings. EN formulas are designed to meet patients' macronutrient needs as well as vitamin and mineral needs with the overall objective of establishing and maintaining quality of life and further preventing undesirable outcomes that are associated with malnutrition. Some individuals who might benefit from a formulation with real food ingredients have not been able to do so because they need a more concentrated, higher calorie formula. Compleat® 1.5 is a calorically dense real food containing nutrition formula. This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, plant-based enteral formula with real food ingredients, Compleat® 1.5, in medically stable adults, who currently require or will require to be enterally fed.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1R 7A5
      • Bruyere Research Institute - Bruyère Continuing Care Complex Care Program - St Vincent Hospital, 60 Cambridge St N

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Medically stable, enterally tube-fed adults with a feeding tube diameter of at least 8 French OR medically stable, adults assessed to require enteral feeding initiation with a feeding tube diameter of at least 8 French (2.6 mm).
2. Aged 18 years or older at the time of screening visit.
3. Currently tolerating or determined to tolerate enteral feeding and eligible for feeding with a 1.5 kcal/mL formula, as per PI discretion.
4. Requires or will require enteral tube feeding to provide 90% or more of their daily nutritional needs without the use of modular(s) for at least 14 days.
5. Participant or their Legally Authorized Representatives (LAR) is willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary informed consent (or assent, if capable), carry out all study-related procedures, and communicate effectively with the study staff.

Exclusion Criteria:

1. Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
2. Currently using the study formula
3. Any medical condition or contraindicated medications deemed exclusionary by the PI as determined by medical/medication history at the time of screening visit.
4. Any condition, in the opinion of the PI, that would contraindicate use of the study formula (e.g., need for severe fluid restriction, allergy to formula ingredients, etc.).
5. Participation in another interventional clinical study between 30 days prior to screening visit until the end of study.
6. Any condition or abnormality that, in the opinion of the QI, would compromise the safety of the participant or the quality of the study data.
7. Unable to obtain informed consent.

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
Experimental: Enteral Nutrition (EN) Formula; Enteral formula	Other: Compleat 1.5; EN Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional adequacy (caloric goals)	Daily percentage of caloric nutritional goal met for each participant	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional adequacy (protein intake)	Daily percentage of protein goal met for each participant	14 days
Frequency of vomiting	Daily report of frequency of vomiting for each participant	14 days
Frequency of abdominal pain	Daily report of frequency of abdominal pain for each participant	14 days
Frequency of abdominal distention	Daily report of frequency of abdominal distention for each participant	14 days
Frequency of reflux	Daily report of frequency of reflux for each participant	14 days
Adverse events Adverse events	Frequency and nature of adverse events (AEs).	14 days
Frequency of nausea	Daily report of nausea for each participant	14 days
Daily stool description and frequency - Bristol stool scale	Daily stool description and frequency (Bristol stool scale) for each participant	14 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.; Bruyere Research Institute
• Investigators: Principal Investigator: Jean Chouinard, MD, Bruyere Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

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

• Keywords: nutrition; enteral nutrition; gastrointestinal; tube feeding
• Other Study ID Numbers: N02-20-02-T0005; 23.01.CA.HCN (Other Identifier: Sponsor)

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