PARTICIPATION IN A PHARMACOLOGICAL HYPOLIPEMIC TRIAL DOES NOT ALTER PARTICIPANTS DIETARY HABITS

Objective: The aim of this study was to observe whether the act of par ticipation in a well-controlled clinical trial can, co-incidentally, m odify the dyslipaemic patient's adherence to his/her diet. Design and Subject: Food diaries of 55 men and 51 women (aged 47.4 +/- 10.6 and 5 5.8 +/- 12.1 years respectively) were analyzed at the beginning and th e end of the double-blind stage of treatment (12 weeks). Statistics: V ariance analysis and multi-variant analysis with repeated data by SPSS /PC statistical package. Results: In either sex were there any statist ically significant differences between the start and end of the study with respect to the intake of energy, proteins, total lipids, carbohyd rates, saturated fatty acids, polyunsaturated fatty acids, cholesterol , fibre and alcohol. Conclusions: Although in individual cases some ch anges in dietary awareness can occur, on a larger scale, the hypochole sterolaemic intervention trial induced no significant overall changes in the participants dietary/lifestyle patterns and, as such, augurs we ll for other such trials in which the effect of the therapy may someti mes be confounded by changes in the patients' life-style patterns coin cidental to the act of participation in the trial.