Document Detail


Evaluation of dietetic product innovations: the relative role of preclinical and clinical studies.
MedLine Citation:
PMID:  20664222     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A variety of systems are used to establish efficacy of food ingredients. Immortal human cell lines have the advantage of rapid throughput and often have the ability to point to mechanisms of action. Transgenic and natural variants of animals (usually rats and mice) have proven to be extremely useful in elucidating effects in vivo, although extrapolation of results to humans has risks. Animal models are also useful in establishing safety and toxic levels of ingredients. Human trials have the most relevance to society. Types of evidence for efficacy rise from improved status level in subjects as a result of eating food (long-chain polyunsaturated fatty acid, levels in erythrocytes), change in surrogate markers as a result of eating food (plasma cholesterol or glutathione peroxidase activity), change in a physiological outcome (such as visual evoked potential acuity or heart rate variability) through to the highest level of evidence, a change in a clinical outcome (improved global development, reduction in infections) established in randomized controlled trials. Ultimately, there is a need for tests of pragmatic interventions that can easily be incorporated into usual dietary practices of the culture in which it is tested.
Authors:
Maria Makrides; Robert A Gibson
Publication Detail:
Type:  Journal Article; Review     Date:  2010-07-21
Journal Detail:
Title:  Nestlé Nutrition workshop series. Paediatric programme     Volume:  66     ISSN:  1661-6677     ISO Abbreviation:  Nestle Nutr Workshop Ser Pediatr Program     Publication Date:  2010  
Date Detail:
Created Date:  2010-07-28     Completed Date:  2011-01-03     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101244056     Medline TA:  Nestle Nutr Workshop Ser Pediatr Program     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  143-50     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 S. Karger AG, Basel.
Affiliation:
Women's and Children's Health Research Institute and University of Adelaide, Adelaide, S.A., Australia.
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MeSH Terms
Descriptor/Qualifier:
Animals
Biomedical Research* / methods
Child
Child Nutrition Disorders / diet therapy*,  immunology
Child, Preschool
Diffusion of Innovation*
Food Technology*
Food, Formulated / adverse effects*,  analysis
Humans
Infant
Infant Food / adverse effects,  analysis
Infant Formula / chemistry
Infant Nutrition Disorders / diet therapy*,  immunology
Infant, Newborn
Research Design

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