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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3
EN Formula
Bruyere Research Institute - Bruyère Continuing Care Complex Care Program - St Vincent Hospital, 60 Cambridge St N
Ottawa, Ontario, Canada
Nutritional adequacy (caloric goals)
Daily percentage of caloric nutritional goal met for each participant
Time frame: 14 days
Nutritional adequacy (protein intake)
Daily percentage of protein goal met for each participant
Time frame: 14 days
Frequency of vomiting
Daily report of frequency of vomiting for each participant
Time frame: 14 days
Frequency of abdominal pain
Daily report of frequency of abdominal pain for each participant
Time frame: 14 days
Frequency of abdominal distention
Daily report of frequency of abdominal distention for each participant
Time frame: 14 days
Frequency of reflux
Daily report of frequency of reflux for each participant
Time frame: 14 days
Adverse events Adverse events
Frequency and nature of adverse events (AEs).
Time frame: 14 days
Frequency of nausea
Daily report of nausea for each participant
Time frame: 14 days
Daily stool description and frequency - Bristol stool scale
Daily stool description and frequency (Bristol stool scale) for each participant
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Time frame: 14 days