Effects of hydroxytyrosol on protection of LDL particles from oxidative damage: a randomized, double-blind, placebo-controlled cross-over study
- Conditions
- o disease, healthy volunteers
- Registration Number
- DRKS00010859
- Lead Sponsor
- Wacker Chemie AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Body mass index (BMI) between 19 and 30 kg/m²
-Non-smoker
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Subject is able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator
- Not anticipating any planned changes in lifestyle regarding activity and nutrition
- Subject is in good physical and mental health
- Clinically normal findings for haematology and clinical chemistry (or clinically insignificant)
- Cholesterol >250 mg/dL, LDL-cholesterol >160 mg/dL, triglycerides >150 mg/dL
- Significant cardiovascular disease or co-morbidities (e.g. stroke, diabetes)
- Known allergy to ingredients of study preparation
- Use of drugs and dietary supplements with lipid-modifying and anti-oxidative properties that could interfere with the study 2 months before or during the study (e.g. statines, phytosterines, omega-3 fatty acids, vitamin use (e.g. vitamin C, vitamin E) or further antioxidative supplements (e.g. OPC, curcumin).
- Use of hypertensive drugs (e.g. ß-blocker, hypertensiva)
- Female patients that are pregnant or nursing
- Fat malabsorption (Crohn’s or celiac disease, cystic fibrosis)
- Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s IBS, IBD, peptic ulcers, celiac, reflux disease)
- Gall bladder resection
- Chronic intake of substances affecting blood coagulation (e.g. acetylsalicylic acid, anticoagulants, diuretics, thiazides) which in the investigator’s opinion would impact volunteer safety
- Donation of blood within the previous 4 weeks before screening
- Participation in a clinical trial with an investigational product within 4 weeks before screening
- Known alcohol abuse or drug abuse
- Known infection with human immunodeficiency virus (HIV) or hepatitis B or
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigation of change of oxLDL-concentration (Oxidized LDL cholesterol ) in serum before and after 4 weeks of supplementation<br>
- Secondary Outcome Measures
Name Time Method -Clearence of Hydroxytyrosol and metabolites in urine after 4 weeks supplementation and in comparison with products<br>- Change of lipid status (total cholesterol, LDL-cholesterol, HDL-cholesterol and trigylcerides) after 4 weeks supplementation and in comparison with products<br>- Hydroxytyrosol and metabolite content in LDL particles after 4 weeks supplementation (LC-MS/MS technology)<br>