E78
Conditions
Interventions
Group 1: verum 1: dietary supplement with tocotrienols (4.5 mg per capsule) and polymethoxylated flavones (PMF
40.5 mg per capsule). One capsule twice a day together with food, un-chewed.
Group 2: verum 2: dietary supplement with tocotrienols (8.3 mg per capsules) and polymethoxylated flavones (PMF
16.3 mg per capsules). One capsule twice a day together with food, un-chewed.
Group 3: placebo. One capsule twice a day together with food, un-chewed.
Sponsors
Leibniz Universtiät Hannover
Institut für Lebensmittelwissenschaft und Humanernährung
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Caucasians, LDL-C = 130 mg/dL (= 3.3 mmol/L) and, persisting hsCRP = 2 mg/L, written confirmation of participants after detailed oral and written explanation about the study contents, and - requirements, ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the dietary study supplements according to the dosage recommendation)
Exclusion criteria
Exclusion criteria: Triglyceride = 400 mg/dL (= 4,5 mmol/L). Total Cholesterol = 500 mg/dL (= 13 mmol/L). hsCRP = 10 mg/L. Body-Mass-Index (BMI) = 35. Simultaneous treatment with lipid lowering medication (e. g. Fibrates, bile acid exchanger resin, phytosteroles, Ezetimibe). treatment with HMG-CoA-reductase inhibitors (statins) in the last three month. Simultaneous consumption of coagulation-inhibiting drugs (for example Marcumar) routine consumption of laxative. taking any supplements with omega-3 fatty acids, Vitamine E, phytosteroles, polyglucosamines (Chitosan) or other lipid binding ingredients. heavy chronic diseases (tumors, diabetes typ 1, etc.), documented coronary heart disease, blood clotting disorders, renal failure, liver diseases. chronic inflammatory diseases (e. g. Colitis ulcerosa, Morbus Crohn, rheumatoid arthritis). allergy or intolerance to any ingredients of the test products. common exclusion criterias like o pregnancy and lactation o alcohol-, drug- and/or medicament dependence o subjects who are not in agreement with the study conditions o refusial or rather reset of the consent from the subject o active participation in other clinical trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-Cholesterol, fasting blood sample every examination (week -2, week 0, week 6, week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid parameters (TC, TG, HDL), Inflammation parameters (hsCRP, TNF-a), Liver enzymes: AST, ALT, ?GT, Blood glucose, Blood picture, Anthropometric data (height, weight, BMI) Blood pressure and pulse, Family anamnesis. Fasting blood sample and questionnaires every examination (week -2, week 0, week 6, week 12). | — |
Countries
Germany
Contacts
Public ContactStefanie Plötz
Leibniz Universtät Hannover Institut für Lebensmittelwissenschaft und Humanernährung
Outcome results
None listed