Hypercholesterolemia E78
Conditions
Interventions
Group 1: for 12 weeks daily 1 Artichoke capsule (Verum 1) + 1 Lactobacillus capsule (Verum 2):
Artichoke leaf extract preparation (Verum 1)
The (brown) capsules contain a dry extract of artichoke le
the DEV of the final extract is 4-6:1.
One artichoke capsule (capsule size 0) has a total weight of 501 mg and contains:
400 mg Artichoke dry extract (corresponding to 1.6 to 2.4 g fresh artichoke) wi
Sponsors
Institut für Lebensmittelwissenschaft und Humanernährung
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: LDL-cholesterol concentration = 4.1 mmol/l that are not intended for statin treatment; or reject it, written consent of the subjects after detailed oral and written information on the study contents, requirements and risks, ability and willingness of the study participants to follow the instructions of the investigator (compliance with the study conditions, use of the test products according to the dosage recommendation, etc.), willingness to take part on the whole study procedure
Exclusion criteria
Exclusion criteria: LDL-cholesterol 35 kg/m2, intake of lipid and especially cholesterol-lowering drugs (e.g., statins, fibrates, bile acid exchange resins, phytosterols, ezetimibe) within the last three months before the planned start of the intervention, use of dietary supplements that affect the lipid- and cholesterol levels (omega-3 fatty acids, phytosterols, polyglucosamine or other lipid adsorbing substances) four weeks before and during the study, severe chronic diseases (tumor, diabetes type 1, etc.), manifest cardiovascular diseases (e.g. angina pectoris, heart failure), renal insufficiency, liver disease, intake of immunosuppressives or chronic corticosteroids, known allergy or intolerance to artichokes or other ingredients contained in the preparation, chronic diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease, pancreatic insufficiency), surgery of the heart (stent, bypass, pacemaker) or digestive tract (exceptions: removal of cecum or gallbladder), regular intake of laxatives, imminent surgical procedures, alcohol, drug and/or medicines addiction, intake of antibiotics three months before study begin (for those participants who collect a fecal sample), persons unable to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-cholesterolconcentration | — |
Secondary
| Measure | Time frame |
|---|---|
| other serum lipids (triglycerides, total cholesterol, HDL-cholesterol), oxLDL, sdLDL, hsCRP, fasting blood glucose, MDA, ADMA, Blood count, AST, ALT, ?GT, Height, Weight, BMI, Blood pressure, arterial stiffness via carotid-femoral pulse wave velocity (PWV), socio-demographic parameters: age, sex, last graduation, profession, marital status, food habits: Food Frequency Questionnaire, Medication and dietary supplement intake, Smoking status, Gastrointestinal Symptom Rating Scale (GSRS), Short Form Health Survey (SF-36), gut microbiota composition | — |
Countries
Germany
Contacts
Public ContactTheresa Greupner
Institut für Lebensmittelwissenschaft und Humanernährung
Outcome results
None listed