The results of the Phase II HEART clinical study were published on June 13, 2022.
This multicentric, international, randomized, placebo-controlled, double-blind study involved 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<0,01). 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<0.01);
- a significant 14% reduction in blood triglyceride level, compared to placebo (p<0.05).
Analyses in 84 volunteers with blood LDL cholesterol levels above 130 mg/dl at randomization, the commercially targeted population of TOTUM•070, demonstrate:
- An increased and lasting efficacy of TOTUM•070 on blood LDL cholesterol levels, with a reduction of 13.7% after three months and 14.3% after six months, compared to placebo.
- A very high response rate to TOTUM•070, reaching 92.5% of responders, from three months in this subpopulation and up to 100% responders when cholesterol levels at baseline exceeded 160 mg/dl.
In addition, the study confirmed the safety and very good tolerance of TOTUM•070.
The comprehensive data from the study will be presented at international scientific conferences.
Previously, an open label bioavailability and mode of action study was led on 10 volunteers. Published in March, 2022, the positive results validated the bioavailability of TOTUM•070 metabolites and their effects on human liver cells in vitro.