A polyphenol-rich active substance (TOTUM-070) lowers LDL-cholesterol in subjects with moderate hypercholesterolemia. The OLALIP study

Background/Introduction Hypercholesterolemia is a major risk factor for cardiovascular diseases. Some polyphenols have shown promising potential in modulating circulating cholesterol. The polyphenol-rich active substance TOTUM-070 (T070) is a blend of five plant extracts that have previously demonstrated beneficial effects in preclinical models, and in subjects with moderate hypercholesterolemia when used at 5g/day for 12 weeks (the HEART study NCT04760951). Purpose The OLALIP study is an open-label, single-centre, single-arm, clinical trial designed to assess the effects of consuming TOTUM-070 at 2.5g/day for 6 weeks on lipid metabolism in individuals at an increased cardio-metabolic risk. Methods Thirty-one subjects were recruited, including men and women aged 18 to 70 years, with a BMI ranging from 18.5 to 35 kg/m2, and moderate hypercholesterolemia not requiring immediate pharmacological lipid-lowering treatment. The subjects received a daily dose of 2.5g of T070, divided into two administrations (BID), for 6 weeks. The primary outcome was to evaluate the effect of T070 on LDL-cholesterol (assessed by Friedewald formula). Secondary outcomes included the effects on total cholesterol (TC), HDL-cholesterol, non-HDL cholesterol, triglycerides, Apo-A1, Apo-B and free fatty acids (FFA). Results A total of 31 subjects completed the study (21 males and 10 females; age: 48.9 ± 11.5 years; BMI 26.6 ± 2.9 kg/m2). After 6 weeks of supplementation, LDL-cholesterol decreased by 10% (1.31 ± 0.2 vs 1.46 ± 0.2 g/L at baseline, p<0.0001). In a subpopulation of subjects with a baseline LDL-cholesterol level ≥ 1.3 g/L (n=23), the reduction in LDL-cholesterol reached 13% (p<0.0001). Moreover, 96% of the subjects in this subpopulation presented reduced LDL-cholesterol levels after 6 weeks of T070 supplementation. Among the secondary outcomes, there was a decrease in TC (-8%, p<0.0001), non-HDL cholesterol (-11%, p<0.0001), Apo B (-7%, p<0.05) at the end of the supplementation period. HDL-cholesterol was not significantly modified. Conclusion The polyphenol-rich active substance T070 showed beneficial effects on hypercholesterolemia when administered at a daily dose of 2.5g for 6 weeks. This represents half the dose and duration of previous studies, highlighting the relevance of using T070 in the management of hypercholesterolemia.