What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Personalized Dietary Plan, Oral (Poly)phenol Challenge Test (OPCT), or General Dietary Advice. The registry lists allocation as randomized. This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response.
They plan to enroll about 330 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (PRE-CARE-DIET)
Interventions: Personalized Dietary Plan, Oral (Poly)phenol Challenge Test (OPCT), General Dietary Advice
Primary outcome (registry wording): Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation