Effects of Avocado Consumption on Gastrointestinal and Cognitive Health: Protocol for the Persea Americana for Total Health-2 (PATH-2) Randomized Crossover Clinical Trial

Objectives: Twenty-percent of adults living in Puerto Rico (PR) have type 2 diabetes (T2D) and 66% are classified with overweight or obesity.The Mediterranean diet (MedDiet), rich in olive oil and nuts, is linked to a 52% lower risk of T2D and improved cardiovascular health.However, these foods are not typical in Puerto Rican diets.Few studies have assessed whether a MedDiet culturally adapted to non-Mediterranean populations would offer similar benefits.Methods: PRECISION is a two-year parallel randomized clinical trial evaluating if a culturally adapted MedDiet using Puerto Rican foods and behavioral strategies can reduce cardiometabolic risk for T2D.Eligible participants aged 30-65y must have at least one risk factor: BMI 25kg/m 2 , waist circumference 94 cm (men) or 80 cm (women), hypertension, prediabetes, or dyslipidemia.Exclusions include diabetes, pregnancy, or conditions affecting diet.Participants are randomized into two arms: an intervention group receiving culturally tailored portion-controlled nutrition counseling, educational daily texts, and monthly supplies of legumes, plant-based oils, and locally sourced produce for 18 months; and a control group receiving standard portion-control counseling, daily texts, and $85 supermarket vouchers for 18 months.There is a 6-month maintenance phase.Clinical and laboratory measures (including fecal samples and metabolites analysis) and comprehensive questionnaires on behavioral and psychosocial factors are collected at baseline and every six months for two years.Implementation metrics are also collected.Primary outcomes include changes in the 10-year atherosclerotic CVD (ASCVD) risk score and a Cardiometabolic Improvement Score.Secondary outcomes assess dietary intake, diet quality, satisfaction, and behaviors.Data will be analyzed as intention-to-treat, following CONSORT guidelines.Results: N/A Conclusions: PRECISION is expected to enable food access, elucidate mechanisms of action of a healthy diet, and improve cardiometabolic health in a high-risk population.The results will inform T2D-prevention programs and policies in PR and serve as model for other culturally tailored trials.