Effect of a dietary supplement with tocotrienols and polymethoxylated flavones (PMF) on serum lipid parameters in probands with hypercholesterolemia and elevated hsCRP levels
- Conditions
- E78Disorders of lipoprotein metabolism and other lipidaemias
- Registration Number
- DRKS00000589
- Lead Sponsor
- eibniz Universtiät HannoverInstitut für Lebensmittelwissenschaft und Humanernährung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 225
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)
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
opregnancy and lactation
oalcohol-, drug- and/or medicament dependence
osubjects who are not in agreement with the study conditions
orefusial or rather reset of the consent from the subject
oactive participation in other clinical trial within the last 30 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL-Cholesterol, fasting blood sample every examination (week -2, week 0, week 6, week 12)
- Secondary Outcome Measures
Name Time Method ipid parameters (TC, TG, HDL), Inflammation parameters (hsCRP, TNF-a), Liver enzymes: AST, ALT, ?GT, Blood glucose, Blood picture, Anthropometric data (height, weight, BMI)<br>Blood pressure and pulse, Family anamnesis. Fasting blood sample and questionnaires every examination (week -2, week 0, week 6, week 12).