Baseline Characteristics in a Randomized Placebo-Controlled Study of the Effects of the Six Plant Extracts Combination Totum-854 on Blood Pressure Management: The Insight Study

Objective: Arterial Hypertension (AHT) is a major cause of premature death worldwide. Polyphenolic compounds have shown promising effects in hypertension management. TOTUM-854 (T-854), a polyphenol-rich composition derived from six plant extracts, has potential in reducing the risk of developing AHT. The primary aim of this study is to evaluate the efficacy of T-854 in reducing systolic blood pressure in individuals with moderately elevated blood pressure. Design and method: The INSIGHT clinical trial is a multi-center, multi-country, randomized, double-blinded study, evaluating T-854 in individuals with high-normal and grade I hypertension who are not on medication affecting blood pressure. This trial assesses the impact of 3.71g of T-854 daily over 12 weeks on systolic blood pressure (SBP) reduction (AOBP, Automated Office Blood Pressure). Secondary objectives include effects on diastolic AOBP, blood lipids, glucose levels, hsCRP and anthropometric parameters. Results: A total of 412 participants (men 60% and women 40%) have been recruited across 3 countries, with a mean age of 45 years. According to the inclusion criteria, the population consists of individuals with high-normal (47%) or grade I hypertension (53%). A significant proportion exhibits anthropometric abnormalities (45% overweight, 25% obese). Some participants also show moderate metabolic abnormalities, notably total cholesterol over 5 mmol/L (49%) and fasting blood sugar levels above 5.5 mmol/L (25%). These characteristics align with those typically found in the general population, where elevated blood pressure often coexists with metabolic disorders related to overweight and obesity. Conclusions: In conclusion, the recruited population meets the study's inclusion criteria and is well-suited to evaluate the efficacy of T-854 in managing moderately elevated blood pressure. The study results are anticipated in mid-2024.