Nutritional Tolerance and Safety of a Tube Feeding Formula

NCT ID: NCT05848583

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-11-15

Brief Summary

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.

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.

Conditions

Enteral Feeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Enteral Nutrition (EN) Formula

Enteral formula

Group Type: EXPERIMENTAL

Compleat 1.5

Intervention Type: OTHER

EN Formula

Interventions

Compleat 1.5

EN Formula

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bruyère Health Research Institute.

OTHER

Sponsor Role: collaborator

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

NETWORK

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Chouinard, MD

Role: PRINCIPAL_INVESTIGATOR

Bruyère Health Research Institute.

Locations

Bruyere Research Institute - Bruyère Continuing Care Complex Care Program - St Vincent Hospital, 60 Cambridge St N

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

23.01.CA.HCN

Identifier Type: OTHER

Identifier Source: secondary_id

N02-20-02-T0005

Identifier Type: -

Identifier Source: org_study_id