NCT05848583

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Compleat 1.5	EN Formula

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2023-05-08
• Last updated: 2024-11-06

Locations

1 site across 1 country: Canada