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N-Of-1 Protocol

Meaning

The N-Of-1 Protocol, also known as a single-subject trial, is a rigorous clinical study design where an individual patient is the sole participant, acting as their own control. This methodology involves alternating periods of an intervention (e.g., a specific supplement or lifestyle change) with control periods (e.g., placebo or baseline state) multiple times in a randomized, blinded fashion. The protocol is used to determine the unique efficacy or safety of an intervention for that specific person. It provides the highest level of evidence for personalized medicine, moving beyond population averages to assess individual response.