E78
Conditions
Interventions
Group 1: verum 1: dietary supplement with 200 mg red yeast rice (3 mg monacoline per tablet)
0,5 mg Astaxanthin
0,2 mg folate and 2 mg Coenzym Q10. One capsule once a day together with the evening meal, un-chewed.
Group 2: placebo. One capsule once a day together with the evening meal, un-chewed.
Sponsors
Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - men and women at the age of 18-70 years - LDL-C =160mg/dl and =220mg/dl - proband's written agreement to investigation after oral and written education about study content, demands and risks - proband's willingness to consume one tablets per day - proband's willingness to follow the given recommendations concerning nutrition and physical acitvity
Exclusion criteria
Exclusion criteria: • LDL-Cholesterol 35 kg/m2 • Bloodpressure: >160mmHg systolic oder >100mmHg diastolic • severe chronic illness (manifest coronary heart disease, cancer) • insulin-dependent diabetes mellitus Typ I and II • severe kidney or liver diseases • chronic gastroinestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas) and state after gastrointestinal surgical procedure e.g. nontropical sprue, short bowel syndrome) chronic inflammatory bowel disease not: appendicitis, gallstone surgery • hormonelle Störungen, beispielsweise Morbus Cushing und nicht behandelte Hyperthyreose • Hormonal disorders, for example, Cushing's syndrome and untreated hyperthyroidism • Intake of a statin and/ or statin therapy in the last 3 months before the baseline examination • Intake of prescribed lipid-lowering agents, inculding fibrates, bile acid binders, ezetimibe, nicotinic acid • Upcoming conversion or change of dosage of following medications: corticosteroids (oral), contraceptives, hormone replacement therapy, thiazide diuretics, beta-blockers, antidiabetics • Hypersensitivity to lovastatin or against one of the components of the investigational product or placebo • Aktive Lebererkrankung oder persistierende Erhöhung der Serum-Transaminasen • Actibe liver disease or persistent elevations of serum transaminases • Cholestasis • Use of nutrient supplements wich exert an effect on LDL levels and other lipid parameters such as: supplements with alpha-linolenic acid (ALA), beta-glucans (such as oats), betaine, Ketosan, glucomannan, guar resins, hydropropylmethylcellulose (HPMC), linoleic acid, red rice products, oleic acid, pectins, plant sterols / stanols and their esters • Myopathy or unexplained mucle pain • insufficient/ no contraception • pregnancy/ lactation • addiction to alcohol and/or drugs • missing consent • refusing / reset of the consent • simultaneous participation at another clinical trial or participation within the last 30 days • planned changes in diet, intensive training (strenght or endurance) planned surgery in the next 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-Cholesterol from week 0 to 6 and week 0 to 12 compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Moreover, changes of the following parameters from week 0 to 12 and week 0 to 6 will be investigated • HDL-Cholesterol, Total-cholesterol and triglycerides • Bloodglucose, Insulin • hs-CRP • Homocysteine • PROCAM-Score | — |
Countries
Germany
Contacts
Public ContactKatharina Möller
Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Outcome results
None listed