Journal of Nutrition and Dietetic Practice

Abstract

Complete Oral nutritional Supplements: Compliance, Palatability, Tolerance In Healthy Volunteers

Author(s): Pauline Uí Dhuibhir, Lorraine Spotten, Brenda O’Connor, Niamh O’Donoghue, Declan Walsh

Introduction: Malnutrition is common in acute and chronic illness. Oral Nutritional Supplements (ONS) augment oral intake when food consumption is insufficient. All new ONS require acceptability testing prior to human use. ONS success depends on patient acceptability. This acceptability study examined 1) palatability, 2) compliance 3) gastrointestinal (GI) tolerance of a product range of six ONS in healthy volunteers. 
Methods: The study design met the standardised clinical safety requirements outlined in Directive 2001/20/EC of the European Parliament and Council, (2001) for the conduct of acceptability studies of medicinal products prior to human use. ONS were taste-tested for Palatability by sensory panels.Volunteers taste-tested ONS daily for thirty days for Compliance and GI Tolerance. 
Results: Palatability (n=20): The mean Palatability rating for all six products was 6 (SD +/-1.5); (1= dislike extremely; 9= like extremely). Compliance evaluation (n=134) showed ≥90% of volunteers consumed the prescribed ONS amount for the entire thirty days. GI Tolerance (n=134) was excellent with side effects mild in nature and of short duration. 
Conclusion: This acceptability study demonstrates a suitable methodology that adheres to EU clinical safety requirements. Palatability and Compliance were uniformly high, consistent and sustained. GI side effects were uncommon, mild and brief. The tested ONS were palatable, acceptable and well tolerated in healthy adults.

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