Mechanisms of Action and Therapeutic Synergies Between Nutrition, Physical Activity, and Phytotherapy for Cardiometabolic Prevention: A Narrative Review and Integrative Framework for the African Context

This repository hosts the complete study materials for the "TRI-SYNERGY" (TRI-pillar SYNERGY for Cardiometabolic Health) trial—a 12-week, randomized, controlled, 2×2×2 factorial clinical trial investigating the individual and synergistic effects of an integrated lifestyle and phytotherapeutic intervention on cardiometabolic risk factors in African adults. Scientific Background: The rising burden of cardiometabolic diseases in sub-Saharan Africa demands innovative, culturally relevant, and scientifically grounded prevention strategies. This protocol is based on a theoretical framework proposing that combining nutrition, physical activity, and phytotherapy can yield synergistic benefits by converging on shared pathophysiological pathways—insulin resistance, chronic low-grade inflammation, oxidative stress, and endothelial dysfunction. Primary Objectives: 1. To evaluate the individual efficacy of each intervention component: a culturally adapted cardioprotective diet, a supervised moderate-intensity physical activity program, and standardized phytotherapy supplementation. 2. To test the hypothesis of synergistic effects (non-additive interactions) between these interventions on key cardiometabolic outcomes. 3. To assess the feasibility, acceptability, and safety of this integrative approach in an African setting. Repository Contents: · TRI-SYNERGY_Protocol_v1.0.pdf – Full study protocol detailing trial design, eligibility criteria, intervention descriptions, outcome measures, and statistical analysis plan. · SPIRIT_Checklist_TRI-SYNERGY.pdf – Completed SPIRIT 2013 checklist ensuring comprehensive protocol reporting. · Informed_Consent_Form_English.pdf – Participant information sheet and consent form (English version). · Case_Report_Forms_Templates.zip – Templates for electronic Case Report Forms (eCRFs) used for data collection. · Statistical_Analysis_Plan_Preregistered.pdf – Preregistered detailed statistical analysis plan (SAP). · Supplementary_Material_LocalFoodGuide.pdf – Visual food guide adapted to the local dietary context for the nutrition intervention. · Ethics_Approval_Document.pdf – Approval letter from the relevant Institutional Review Board/Ethics Committee (to be uploaded upon receipt). · Trial_Registration_Details.pdf – Proof of registration in a public clinical trials registry (e.g., ClinicalTrials.gov, PACTR).