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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