An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition

Study Overview
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Brief Summary
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This study aims to investigate the efficacy of high energy, low volume oral nutritional supplements (ONS) compared to equivalent standard ONS (control) to maximize nutrient intake, compliance, gastro intestinal tolerance and function, in participants at risk of malnutrition.

Detailed Description
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In current clinical practice malnourished (undernourished) patients may receive oral nutritional supplements (ONS) to aid in the management of their malnutrition (undernutrition). Poor compliance to ONS was been reported in the scientific literature, however recent studies of a low volume, high energy ONS have shown high compliance. This study aims to further explore compliance to low volume ONS compared to standard ONS. This study is a 2 week cross over study with a 4 week optional extension. Participants at risk of malnutrition will receive a low volume, high energy ONS for 1 week and a standard ONS for 1 week in a random order to compare nutrient intake and compliance. This short term element of the study was designed based on a similar study by Hubbard et al 2009, where significant differences in compliance and energy intake were observed. Participants may then take part in an optional 4 week extension period where they will receive their preferred ONS for 4 weeks. Longer term outcomes such as change in weight, muscle function and tolerance to the ONS will be measured in this part of the study. Changes in weight and muscle function are typically seen in 4 weeks. Overview of the study: Participants will be assessed for inclusion and exclusion criteria by the investigating dietitian or research nurse, and then provided with information about the study. Eligible participants will be asked for their written informed consent. Participant characteristics and medical history will be collected. Participants will be randomly allocated to receive either: A. A standard ONS (1.5kcal/ml) as control, ad libitum in addition to diet for 7 days. Participants will then receive the high energy, low volume equivalent ONS (2.4kcal/ml) ad libitum in addition to diet for 7 days (n=70), or: B. A high energy, low volume ONS (2.4kcal/ml) ad libitum in addition to diet for 7 days. Participants will then receive the equivalent standard ONS (1.5kcal/ml) as control, ad libitum in addition to diet for 7 days (n=70). Participants will then have an option to continue with their preferred ONS for a further 4 weeks (28 days).

Official Title
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An Investigation of the Efficacy of High Energy, Low Volume Oral Nutritional Supplements in Participants at Risk of Malnutrition

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Standard ONS
* Dietary Supplement: High Energy, low volume 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard ONS<br> | Dietary Supplement: Standard ONS<br>* Standard ONS<br>* Other names: Oral nutritional supplements;|
| Experimental: High Energy, Low volume ONS<br>High energy, low volume ONS | Dietary Supplement: High Energy, low volume ONS<br>* High energy, low volume ONS<br>* Other names: Oral nutritional supplements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrient intake (energy, protein and micronutrients) | Dietary intake, including the intake of all foods, drinks and ONS will be recorded at baseline (day 1), at the end of week 1, at the end of week 2 and at the end of the optional extension period (week 6) using 24 hr dietary recall. A dietary analysis program will be used to calculate intake from food and total dietary intake. | 1week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with ONS | Participants' compliance with ONS (percentage of bottle consumed), will be recorded on a daily basis by the participant or their carer throughout the study. | 1week | 
| ONS Acceptability (taste, aroma) and ONS Preference (which type is preferred) | The acceptability (taste, texture, aroma) and preference for the type of ONS will be assessed (using Yes/No questions and visual analogue scales) to gather patients feedback on the acceptability the the supplements | 1week | 
| Appetite | The effect of the ONS on hunger and fullness will be assessed by questionnaire using visual analogue scales at baseline (day 1), at the end of week 1, at the end of week 2 and at the end of the study (week 6). | 1week | 
| Anthropometry | At baseline as part of screening with MUST, at the end of week 1, at the end of week 2 and at the end of the study (week 6), body weight (kg) will be measured using standard methods and body mass index (kg/m2) calculated. Body weight will be measured to the nearest 0.1kg using a weighing scale or weighing chair without shoes or heavy clothing. | 6weeks | 
| Muscle Strength (Hand Grip Strength) | Hand grip strength will be measured at baseline (day 1), at the end of week 2 and at the end of the study (week 6) using a handgrip dynamometer. | 6weeks | 
| Gastro-intestinal (GI) tolerance | Gastro-intestinal tolerance will be assessed at baseline (day 1), at the end of week 1, at the end of week 2 and the end of week 6 for 1 day, using a standardized GI tolerance questionnaire. | 6weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnourished, Elderly, Nutrition support