Effect of a dietary supplement with red rice on LDL-cholesterol
- Conditions
- E78Disorders of lipoprotein metabolism and other lipidaemias
- Registration Number
- DRKS00006189
- Lead Sponsor
- eibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 155
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
•LDL-Cholesterol <160mg/dl or =220mg/dl
•TG = 220mg/dl
•Body-Mass-Index (BMI) >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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL-Cholesterol from week 0 to 6 and week 0 to 12 compared to placebo
- Secondary Outcome Measures
Name Time Method Moreover, changes of the following parameters from week 0 to 12 and week 0 to 6 will be investigated<br>•HDL-Cholesterol, Total-cholesterol and triglycerides<br>•Bloodglucose, Insulin<br>•hs-CRP<br>•Homocysteine<br>•PROCAM-Score<br>