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

Nutricia UK Ltd18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cancer Neurological Injury Respiratory Disease Stroke

Interventions

High protein liquidOTHER

After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance, dietary intake while also capturing information related to user experience, risk of malnutrition, physical function, dietary intake, anthropometry and safety with their currently prescribed nutritional regimen, each patient will receive the high protein liquid daily for 28 days where the same measures will be replicated. The amount of the high protein liquid prescribed will always be completed by the patients' managing dietitian.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (2)

Western Sussex Hospitals NHS Trust

Worthing, West Sussex, United Kingdom

University Hospitals Bristol

Bristol, United Kingdom

Outcomes

Primary Outcomes

Change in Acceptability

Acceptability of the patients existing feeding regimen (including any protein module use) will be assessed on day 1, baseline period. Acceptability with the study product will be assessed at the end of the intervention period using a standardised questionnaire completed by the patient.

Time frame: 2 days (days 1 and 29)

Secondary Outcomes

Compliance

Compliance with the recommended intake of patients' currently prescribed high protein modular feed (if an existing user) and feeding regimen overall will be assessed separately at baseline. Similarly, compliance with the study product will be assessed daily throughout the intervention period and weekly when considering the patients feeding regimen overall. Compliance data will not be used in calculations for nutrient intake. For daily compliance questions, patients will be asked to record how many servings are taken compared to that recommended by their Health Care Professional (HCP). The daily amount prescribed by the HCP managing the patients care will be recorded at the start of the study and any changes to this prescription during the study will be noted. To strengthen compliance measures for the HPLM only, a count of the HPLM will be conducted on day 29 and compared to amount prescribed at baseline.

Time frame: 29 days

Change in Gastrointestinal tolerance

Gastrointestinal tolerance (including symptoms of diarrhoea, constipation, nausea, vomiting, abdominal pain, bloating, flatulence and burping) and information about bowel movements will be assessed during baseline (day 1), and on days 8, 15 and 29 of the intervention period using a standardised gastrointestinal tolerance questionnaire. This will be completed by the patient or their carer (using the scale: none, mild, moderate, severe symptoms)

Time frame: 4 days (day 1, 8, 15 and 29)

Change in Nutrient Intake (24-hour dietary recall)

During recruitment, on a per patient and condition specific basis, the patients managing Dietitians will calculate estimated energy and protein requirements as per standard dietetic practice. Intake of all nutrition provided (including the HPLM, other enteral tube feeds, foods, drinks and oral nutritional supplements) will be recorded at baseline and at the end of the intervention period via 24 hour dietary recall. Actual intakes will subsequently be compared against Dietitians calculated estimated energy and protein requirements and percentage achievements of these requirements will also be calculated. This will include details of feeding regimens as required. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.

Data from ClinicalTrials.gov

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