Healthy subjects with slight to moderately elevated LDL-cholesterol level.
Conditions
Interventions
Group 1: HTEssence®, equivalent to 30 mg Hydroxytyrosol
Oral, 2x 2 capsules/day (morning and evening)
Duration of intervention 12 weeks
Group 2: Placebo: Maltodextrinx
Sponsors
Wacker Chemie AG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subject is able and willing to sign the Informed Consent Form prior to screening Evaluations; Sex: male and female (at least 30% of each gender); BMI: 18.5 – 35 kg/m²; Adults at total CV risk score < 5 % (SCORE-Germany, moderate risk); At screening LDL-cholesterol =115 and <190 mg/dL; Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Exclusion criteria
Exclusion criteria: Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack); Chronic intake of medication/dietary supplements (e.g. medical lipid reducing therapy according to cardiologic guidelines, phytosterols, red yeast rice, garlic, omega-3 fatty acids etc.) potentially interfering with this study during the last 2 months before screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable. Consumption of a fatty fish and/or seafood meals is greater than twice per month during intervention and 4 weeks prior study start; Fasting triglyceride levels > 350 mg/dl; “Extreme dietary regimes”: vegan lifestyle, weight loss diet with 4.5 kg; Smoker > 10 cigarettes / day; Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s disease, peptic ulcers, celiac disease) Drug-, alcohol- and medication abuses; Known HIV-infection; Known acute or chronic hepatitis B and C infection; Relevant allergy or known hypersensitivity against compounds of the study preparations; Women: pregnancy, breast feeding or intention to become pregnant during the study; Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study; Blood donation within 4 weeks prior study start (screening) or during study; Anticipating any planned changes in lifestyle for the duration of the study; Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of LDL cholesterol prior and after 12 weeks of Hydroxytyrosol intake in comparison to placebo. The analysis of LDL-cholesterol will be perfromed in fasting blood samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of the following parameters between baseline and after 6- and 12 weeks of intake of hydroxytyrosol in comparison to palcebo. Lipid status (total cholesterol, HDL-cholesterol, trigycerides, VLDL, LDL-/HDL-cholesterol ratio) and blood pressure (systolic and diastolic). | — |
Countries
Germany
Contacts
Public ContactJasmin Steudle
BioTeSys GmbH
Outcome results
None listed