No disease, healthy volunteers
Conditions
Interventions
Group 1: HTEssence®: Hydroxytyrosol Powder 20%, hydroxytyrosol (synthetic)
equivalent to 30 mg hydroxytyrosol
Oral, 2x 2 capsules/day (morning and evening), duration of supplementation 4 weeks
Group 2: Olive polyphenol preparation 15%, hydroxytyrosol (natural extract)
Oral, 2x 2 capsules/day (morning and evening), duration of supplementation 4 weeks
Group 3: 355 mg Maltodextrin, Oral, 2x 2 capsules/day (morning and evening)
duration of supplementation 4 weeks
Sponsors
Wacker Chemie AG
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: - 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)
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of change of oxLDL-concentration (Oxidized LDL cholesterol ) in serum before and after 4 weeks of supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| -Clearence of Hydroxytyrosol and metabolites in urine after 4 weeks supplementation and in comparison with products - Change of lipid status (total cholesterol, LDL-cholesterol, HDL-cholesterol and trigylcerides) after 4 weeks supplementation and in comparison with products - Hydroxytyrosol and metabolite content in LDL particles after 4 weeks supplementation (LC-MS/MS technology) | — |
Countries
Germany
Contacts
Public ContactSimone Siefer
BioTeSys GmbH
Outcome results
None listed