PUFA in infant nutrition: Consensus and controversies

Abstract

most of the workshops had a clinical orientation. The organizers were aware that larger trials with infants were a perceived need and realized that many working in the LCPUFA area had little experience with randomized clinical trials (RCT). For those planning new exploratory studies of LCPUFA and development, one workshop dealt with confounding and mediating variables in studies of human neurodevelopment. Another discussed issues essential to the conduct of RCT, particularly how to design studies with sufficient statistical power to reject or accept the null hypothesis. Other workshops provided directions for new studies to explore the basic or mechanistic effects of LCPUFA. Papers from the discussion leaders and workshop directors are included in this issue of Lipids, and they provide a state-of-the-art summary of the topics introduced above. There is a need to look at more outcomes that can be related to n-3 fatty acid deficiency in human infants with different n-3 LCPUFA status. RCT designed to study outcomes affected by LCPUFA status in smaller clinical trials are also needed. Study designs, methods, and populations need to be carefully chosen in future clinical studies and related to the smaller published trials. A study that adheres strictly to RCT methodology, but that is poorly designed or based upon a lack of understanding of the biology of LCPUFA, may be technically excellent but have no biological meaning and value. Because the published effects of feeding LCPUFA on behavior have been small, an additional need for RCT is that they account for evaluator differences, which may mask differences in neural function if adjustments are not made in calculating the statistical power for the study. Because the design of better clinical trials was a major goal of the meeting, the organizers agreed that the true success of the meeting could not be evaluated until the design, methods, and results of new clinical trials are available. Finally, it was noted that mechanistic studies of the effects of LCPUFA in neural development and in other physiological functions are needed. There appears to be an increased interest in conducting such studies since the meeting was held. We hope that some bases for the physiological actions of LCPUFA and new exploratory and clinical work can be available for presentation at the time of the second international meeting in the Fall 2000 in Kansas City, Missouri.