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


METHODS
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.
Arija
V
V
Human Nutrition Unit, Faculty of Medicine and Health Science, Rovira i Virgili University.
Piñol
C
C
Vallés
S
S
Salas
J
J
D000328:Adult; D000368:Aged; D000428:Alcohol Drinking; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D002791:Cholesterol, Dietary / Q000008:administration & dosage; D015930:Diet Records; D004040:Dietary Carbohydrates / Q000008:administration & dosage; D004041:Dietary Fats / Q000008:administration & dosage; D004043:Dietary Fiber / Q000008:administration & dosage; D004311:Double-Blind Method; D002149:Energy Intake; D005227:Fatty Acids / Q000008:administration & dosage; D005247:Feeding Behavior; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D000924:Anticholesteremic Agents; D002791:Cholesterol, Dietary; D004040:Dietary Carbohydrates; D004041:Dietary Fats; D004043:Dietary Fiber; D005227:Fatty Acids