Palatability and Perceived Satiety of Oral Nutrition Supplements

Study Overview
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Brief Summary
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The objective of the study is to evaluate palatability (primary objective) and perceived satiating effects (secondary objective) of two Oral Nutrition Supplements (ONS) prototypes and six commercially available ONS products. The products are matched on calorie content per portion. The study is a single-blind intervention with a within-subjects design. In total 104 apparently healthy and independently living older adults aged 65 will be recruited to participate. Participants will visit the research facilities eight times in a period of one month. On each test-day participants will consume and evaluate a single product.

Official Title
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Palatability and Satiating Effects of Oral Nutrition Supplements as Perceived by Independently Living Older Adults

Conditions
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Sensory Evaluation, Perceived Satiety

Intervention / Treatment
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* Dietary Supplement: Oral Nutrition Supplement (ONS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 years or over Apparently healthy Living independently Exclusion Criteria: Allergies to soy, dairy or gluten Following a specific diet BMI>30 kg/m2 Reduced kidney function Suffering from Alzheimer's disease, Dementia, Parkinson's Disease, Cancer, Kidney Disease or Diabetes Suffering from Dysphagia Already using oral nutritional supplements Receiving any medical treatment that is known to reduce the taste or sense of smell Current smokers Participation in another clinical trial at the same time

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Each study participant evaluates 8 different ONS products on palatability and perceived satiety
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-blind sensory and satiety evaluation<br>In total 8 different ONS products are consumed and evaluated, each product on a separate test day. The order of products is randomized between study participants. | Dietary Supplement: Oral Nutrition Supplement (ONS)<br>* Consumption of a portion of 300-320kcal (based on a standard single serve for ONS products) with a two hour follow-up. Products include: 2 Prototype Oral Nutrition Supplements (ONS) with 2.4kcal/ml and respectively 9.6% protein and 14.4% protein; 6 Commercially available Oral Nutrition Supplements with varying energy and protein levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liking | Questionnaire evaluating overall liking, liking of taste, liking of creaminess, liking of sweetness, liking of thickness and liking of aftertaste on a 11-points categorical scale ranging from 1='do not like at all' to 11='like very much' | Immediately after consumption of one sip of the ONS product | 
| Liking | Questionnaire evaluating overall liking, liking of taste, liking of thickness and liking of aftertaste on a 11-points categorical scale ranging from 1='do not like at all' to 11='like very much' | Immediately after finishing consumption of a full portion of the ONS product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety | Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much' | Before consumption of the ONS product | 
| Satiety | Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much' | Immediately after finishing consumption of a full portion of the ONS product | 
| Satiety | Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much' | 1 hour after finishing consumption of a full portion of the ONS product | 
| Satiety | Feelings of satiety will be evaluated using a standardized questionnaire covering hunger (3 items), thirst (2 items) and fullness (1 item). Each item is answered on a 11-points categorical scale ranging from 1='not at all' to 11='very much' | 2 hours after finishing consumption of a full portion of the ONS product |