Clinical study to investigate lipid modifying effects of hydroxytyrosol – a randomized, double-blind, placebo-controlled parallel study
- Conditions
- Healthy subjects with slight to moderately elevated LDL-cholesterol level.
- Registration Number
- DRKS00015251
- Lead Sponsor
- Wacker Chemie AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 92
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
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 <1200 kcal/day for women and <1800 kcal/day for men; Weight loss intervention or recent body weight change > 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change of the following parameters between baseline and after 6- and 12 weeks of intake of hydroxytyrosol in comparison to palcebo. <br>Lipid status (total cholesterol, HDL-cholesterol, trigycerides, VLDL, LDL-/HDL-cholesterol ratio) and blood pressure (systolic and diastolic).