DESIGN CRITERIA FOR STUDIES EXAMINING INDIVIDUAL FATTY-ACID EFFECTS ON CARDIOVASCULAR-DISEASE RISK-FACTORS - HUMAN AND ANIMAL STUDIES

Studies designed to examine individual fatty acid effects in humans an d animals are critically dependent on subjects or animal species, expe rimental diets, and the experimental design used. For both human and a nimal studies, the numbers of subjects and animals must be adequate fo r achieving statistical significance and the subjects and animals must be grouped appropriately (eg, age, sex, and cholesterol responsivenes s). In animal studies the appropriate species must be selected because some species are unacceptable models. In both human and animal studie s, great attention must be paid to the design of the experimental diet s. Test diets must be tightly controlled and nutrient specifications m ust be met and verified by chemical analysis. Ideally, only the fatty acid of interest should vary among the test diets. Two experimental de signs are appropriate: crossover and parallel-arm designs. Feeding per iods must be of adequate duration for stabilization of endpoints. Atte ntion to these study design issues is imperative for meaningful conclu sions to be reached about the effects of individual fatty acids.