Valbiotis announced the major success of the Phase II HEART clinical study, which achieved its objective of reducing blood LDL cholesterol level (primary endpoint) with TOTUM•070 and confirmed the very good tolerance of this active substance. This multicentric, randomized, placebo-controlled, double-blind study was conducted in 120 volunteers with mild to moderate untreated hypercholesterolemia and tested a daily dose of 5 g in two intakes for 6 months. As early as three months of supplementation, TOTUM•070 significantly reduced blood levels of LDL cholesterol (-13%, p<0.01), and triglycerides (-14%, p<0.05), compared to placebo.

Excess of these blood lipid markers is a cardiovascular risk factor. The HEART clinical study was a multicentric, international, randomized, placebo-controlled, double-blind study involving 120 people with untreated mild to moderate hypercholesterolemia, with blood level of LDL cholesterol between 130 mg/dl and 190 mg/dl. The participants were divided into two equivalent arms of 60 people, supplemented for six months with a daily dose of 5 g of TOTUM•070 or a placebo, in two intakes.

After a 6-month supplementation, the study achieved its objective of significantly reducing LDL cholesterol in the blood (primary endpoint, -9% versus placebo, p<0,015). As early as 3 months of supplementation with TOTUM•070, the results showed a significant lipid-lowering effect, with: a significant 13% reduction in blood LDL cholesterol level, compared to placebo (p<0.015); a significant 14% reduction in blood triglyceride level, compared to placebo (p<0.055). In clinical practice, the reduction of LDL blood cholesterol as early as 3 months of supplementation is an expected benefit by patients and healthcare professionals1.

The HEART study also demonstrates the persistent lipid-lowering effect at 6 months. In addition, the study confirmed the safety and very good tolerance of TOTUM070. The comprehensive data from the study will be presented at international scientific conferences.