Nutritional Supplement Compliance Study

Study Overview
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Brief Summary
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Disease-related malnutrition is common across healthcare settings in the UK and if left untreated, may have severe consequences. One of the strategies commonly used to combat malnutrition is the use of oral nutritional supplements (ONS). However, there is uncertainty about the optimal way of delivering ONS to patients to maximize compliance and nutrient intake. This randomised study will investigate the effect of different modes of delivery (ad libitum versus instructions on timing/serving volume) of ONS used in addition to the diet on total nutrient intake, compliance, nutritional status and outcome in participants at risk of malnutrition. Participants will be randomised to receive one of two ONS (high energy or standard) for 4 weeks in addition to food, either taken 'Ad libitum', or according to instruction on what to take and when. The primary outcome measure is nutrient intake. Secondary outcome measures include compliance and acceptability of ONS, appetite, anthropometry, muscle strength, quality of life and gastro-intestinal tolerance.

Official Title
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An Investigation of the Effects of Different Modes of Delivery of Oral Nutritional Supplements in Participants at Risk of Malnutrition - A Pilot Study

Conditions
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Undernutrition

Intervention / Treatment
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* Dietary Supplement: Standard Oral Nutritional Supplement (ONS)
* Dietary Supplement: High energy Oral Nutritional Supplement (ONS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age > 18 years At risk of malnutrition (medium or high risk of malnutrition with 'Malnutrition Universal Screening Tool', 'MUST' score ≥ 1) Competent to provide written informed consent and able to answer questions No requirement for tube or parenteral feeding Willingness to take part in the study and to follow the study protocol Exclusion Criteria: Requirement for tube or parenteral nutrition Participants receiving palliative care Participants with chronic renal disease requiring dialysis Participants with liver failure Participants that are pregnant or lactating Participation in other studies

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard ONS | Dietary Supplement: Standard Oral Nutritional Supplement (ONS)<br>* Standard energy, oral nutritional supplement (a milk style nutritional supplement (1.5kcal/ml, 200ml) containing protein, fat, carbohydrate and micronutrients)<br>|
| Active Comparator: 2<br>High Energy ONS | Dietary Supplement: High energy Oral Nutritional Supplement (ONS)<br>* High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrient intake (energy, protein and micronutrients) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with ONS |  | 4 weeks |