Protein Top-up Acceptability Study for Patients With Increased Protein Needs

Nutricia

Status

Completed

Conditions

Stroke

Respiratory Disease

Cancer

Neurological Injury

Treatments

Other: High protein liquid

Study type

Interventional

Funder types

Industry

Identifiers

NCT04607330

PROSHT20'

Details and patient eligibility

About

The aim of this prospective, single-arm intervention study is to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs.

Full description

Increased protein needs are frequently observed in disease and can be difficult for patients to achieve where oral food intake is compromised.Where a standard ONS or enteral tube feed cannot meet the needs of patients, a modular feed can be added to the regimen, a low calorie, low volume, ready to use, high protein liquid may help meet protein needs while preventing caloric overfeeding.

40 patients will be recruited in an attempt to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs. After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance and dietary intake with their currently prescribed nutritional regimen, each patient will receive the high protein liquid feed daily for 28 days.

Enrollment

18 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age and older.
Patients under the care of a Dietitian requiring oral or enteral nutritional support, with -increased protein needs.
To receive a minimum of 1 x 40ml HPLM daily (orally or via enteral tube) while on the study.
Informed consent obtained from the patient

Exclusion criteria

Total parenteral nutrition (100% of requirements).
Patients with major hepatic dysfunction (i.e. decompensated liver disease).
Patients with major renal dysfunction (i.e. requiring filtration or Stage 4/5 chronic kidney disease (CKD)).
Participation in other studies within 1 month prior to entry of this study.
Patient with severe lactose intolerance.
Pregnant or lactating.
Patient lacks capacity to consent for themselves.