Oral Nutritional Supplementation
Conditions
Keywords
Oral nutritional supplement, supplementation, adult patients
Brief summary
Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.
Interventions
Oral nutritional supplementation
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion: * Male and female patients * ≥ 18 years of age * Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days * Patient is able and willing to provide written informed consent Exclusion: * Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients * Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine) * Patients who express general dislike to two or more of the four flavours * Severely impaired gastrointestinal function or complete failure * Severe metabolic or circulatory disorders * Acute disease * Unstable vital functions * Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy * Simultaneous participation in another interventional study * Patients who are unwilling or mentally and/or physically unable to adhere to study procedures * Pregnancy * Emergencies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events) | 7 days | Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of further adverse effects | 7 days | — |
| Evaluation of palatability by questionnaire | 1 day | Five point hedonic scale |
| Evaluation of compliance. | 7 days | Comparison of prescription and actual intake |
Countries
United Kingdom