The Niche of n-of-1 Trials in Precision Medicine for Weight Loss and Obesity Treatment: Back to the Future.

Abstract

The n-of-1 clinical trials are considered the epitome of individualized health care. They are employed to address differences in treatment response and adverse events between patients, in a comparative effectiveness manner, extending beyond the delivery of horizontal recommendations for all. The n-of-1 design has been applied to deliver precision exercise interventions, through eHealth and mHealth technologies. Regarding personalized and precision medical nutrition therapy, few trials have implemented dietary manipulations and one series of n-of-1 trials has applied comprehensive genetic data to improve body weight. With regard to anti-obesity medication, pharmacogenetic data could be applied using the n-of-1 trial design, although none have been implemented yet. The n-of-1 clinical trials consist of the only tool for the delivery of evidence-based, personalized obesity treatment (lifestyle and pharmacotherapy), reducing non-responders, while tailoring the best intervention to each patient, through "trial and error". Their application is expected to improve obesity treatment and mitigate the epidemic.