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LDL-cholesterol lowering effect of hydroxytyrosol (HTEssence^®): A randomized double-blind, placebo-controlled parallel study

Katharina Knaub*, Yvonne Modinger, Manfred Wilhelm, Christiane Schon

Background: Nutraceuticals containing hydroxytyrosol have been shown to exert a wide range of beneficial effects on the cardiovascular system like lipid modification and cholesterol reduction. The aim of this randomized doubleblind, placebo-controlled parallel study was to investigate the effects of a pure, synthetic form of hydroxytyrosol (HTEssence^®) on the lipid profile in subjects with elevated LDL-cholesterol level.

Methods: 92 subjects underwent a 12-week intervention with hydroxytyrosol or placebo. At baseline, after 6 and 12 weeks of intervention the lipid profile of the subjects was assessed.The study was conducted in accordance with the guidelines for Good Clinical Practice (GCP) andwas registered in the German Clinical Trials Register (DRKS00015251).

Results: A significant delta change of LDL-cholesterol levels was observed in the hydroxytyrosol group after 12 weeks of intervention comparedto the placebo group (p=0.0454). The absolute difference between placebo and hydroxytyrosol accounted for 8.46mg/dL.With regard to the changes within the intervention groups after 12 weeks, a slight decrease of LDL-cholesterol could be observed in the hydroxytyrosol group (-2.70 mg/dL, 95% CI: -8.15- 2.75) and, in contrast, an increase of this parameter in the placebo group (5.76 mg/dL, 95% CI: 0.23– 11.28). Regarding the other parameters of lipid status including total cholesterol, HDL-cholesterol, LDL/HDL-ratio and triglycerides, no lipid modifying effects were observed.

Conclusion: Data of the current clinical study support the evidence for hydroxytyrosol being a nutraceutical with anti-atherogenic effects.