Nutrition science mustn't accept a lower level of evidence

Randomized Controlled Trials Evaluating Effect of Television Advertising on Food Intake in Children: Why Such a Sensitive Topic is Lacking Top-Level Evidence?

“…The fact that this situation is an incontrovertible pitfall, is in line with Fenton and Fenton's (2011) considerations, namely that nutrition science should not and need not be complacent with lower levels of evidence than is required for other branches of medical science. In this perspective, also in the nutrition field, RCT in one of its variant forms is the study design that best permits strong causal inference concerning the relationship between a factor and any specific outcome (Blumberg et al 2010).…”

Biochemical markers for assessment of calcium economy and bone metabolism: application in clinical trials from pharmaceutical agents to nutritional products

“…Industry is unlikely to sponsor these large RCT because, in contrast to drugs, marketing the products is not dependent on the results of RCT. However, as compared with foods or nutrients, the risk:benefit ratio is much greater with drugs, as they may cause more severe adverse side effects ( 18 , 19 , 24 , 25 ) .…”

“…In order to provide information on medical practice, the needed evidence-based criteria differ for foods and nutrients as compared with drugs. The development of drugs requires a very high level of rigour, more for safety concerns than for providing evidence of efficacy ( 18 , 24 , 25 ) . The present review essentially considers the rationale for using BTM in clinical research on foods or nutrients that influence bone mineral economy and/or metabolism.…”

“…In the osteoporosis context, in order to demonstrate the efficacy of a new medication, regulatory agencies usually require RCT of 3 years’ duration, with fracture as the primary endpoint. In the nutrition field, all types of research are useful in setting dietary recommendations: observational studies, to document prevalence and generate hypotheses; preclinical experiments to identify physiological and biochemical pathways; qualitative studies to understand the human condition; and, finally, RCT, to establish a relationship of causality ( 18 , 24 , 25 , 160 ) .…”

“…An RCT is the clinical study design that best permits strong causal inference between a tested drug or nutrient and a given outcome ( 18 , 20 ) . Previous reviews or position papers have emphasised the distinct differences in the evidence that can be obtained by using RCT in the context of drug testing, as compared with the development of nutrient requirement or dietary guidelines ( 18 , 23 , 24 , 158 , 159 ) . In the osteoporosis context, in order to demonstrate the efficacy of a new medication, regulatory agencies usually require RCT of 3 years’ duration, with fracture as the primary endpoint.…”