Acceptability Study on Oral Nutrition Supplement (ONS)

Study Overview
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Brief Summary
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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.

Official Title
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Acceptability Study on Nutricomp Drink Plus in Adult Patients

Conditions
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Oral Nutritional Supplementation

Intervention / Treatment
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* Dietary Supplement: Nutricomp Drink Plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Nutricomp Drink Plus<br>Nutricomp Drink Plus | Dietary Supplement: Nutricomp Drink Plus<br>* Oral nutritional supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events) | Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of further adverse effects |  | 7 days | 
| Evaluation of palatability by questionnaire | Five point hedonic scale | 1 day | 
| Evaluation of compliance. | Comparison of prescription and actual intake | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplement, supplementation, adult patients