Participation in a pharmacological trial does not alter participants' dietary habits.

Identifier:  PC:1625

Handle: https://hdl.handle.net/20.500.11797/PC1625

Authors:  Jordi Salas; Victoria Arija; Carme Piñol; Sonia Valles

Abstract:
OBJECTIVE: The aim of this study was to observe whether the act of participation in a well-controlled clinical trial can, co-incidentally, modify the dyslipaemic patient's adherence to his/her diet. DESIGN AND SUBJECT: Food diaries of 55 men and 51 women (aged 46.4 +/- 10.6 and 55.8 +/- 12.1 years respectively) were analyzed at the beginning and the end of the double-blind stage of treatment (12 weeks). STATISTICS: Variance analysis and multi-variant analysis with repeated data by SPSS/PC statistical package. RESULTS: In neither sex were there any statistically significant differences between the start and end of the study with respect to the intake of energy, proteins, total lipids, carbohydrates, saturated fatty acids, polyunsaturated fatty acids, cholesterol, fibre and alcohol. CONCLUSIONS: Although in individual cases some changes in dietary awareness can occur, on a larger scale, the hypocholesterolaemic intervention trial induced no significant overall changes in the participants dietary/lifestyle patterns and, as such, augurs well for other such trials in which the effect of the therapy may sometimes be confounded by changes in the patients' life-style patterns coincidental to the act of participation in the trial.