Commonly used definition of the substance |
Definition matches method of analysis |
A method of analyzing the substance consistent with the definition |
Preferably validated by multi-center analysis |
Database of the amount of the nutrient or bioactive in food (and supplements) |
Preferably global and regularly updated |
Prospective Cohort studies |
Both sexes and showing relationship between outcome and dietary intake, or preferably biochemical or clinical indicator |
Clinical trials on digestion, absorption, transport, and excretion of the substance |
Important to understand level of intake, factors affecting absorption, metabolism, and excretion |
Clinical trials on efficacy and dose–response |
Conducted in healthy populations with bioactive being measured along with accepted endpoint or biomarker |
Safety data at anticipated level of intake |
Should include data from special populations, e.g., children, pregnant or lactating women |
Systematic reviews and/or meta-analyses showing efficacy |
Required by IOM for setting DRI and inclusion in DGA recommendations |
A plausible biological explanation for efficacy |
Not required but nevertheless important |