Cardiovascular disease Circulatory System Chronic ischaemic heart disease
Conditions
Interventions
Patients are randomised to:
1. Quercetin 150 mg
2. Placebo
Patients will receive two capsules of one of the above three times a day during principal me
Sponsors
Max Rubner Institute (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteers 2. Aged 45 - 69 years 3. Member of the Metabolic Intervention Cohort Kiel (MICK) 4. Homozygous for ApoE 3 or ApoE 4, or ApoE 3/4 heterozygous 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical study with a medicament or a medicinal product within the last 30 days or simultaneous participation in another clinical examination 2. Inability to understand and to comply with the study protocol 3. Known metabolic or gastro-intestinal diseases, which affect the absorption, metabolism or excretion of food or food components 4. Condition after surgery of the gastro-intestinal tract, which affect gastro-intestinal motility 5. Haemoglobin less than 12 g/dL 6. Ferritin less than 35 µg/L 7. Latex allergy 8. Diabetes (fasting glucose levels greater than 125 mg/dl after repeated determination) 9. Surgery within the last three months, which still affects the current state of health 10. Deformation of finger tips, which inhibits correct recording of the EndoPAT device (measures a Peripheral Arterial Tone [PAT™] signal for assessment of endothelial dysfunction) 11. Illness of thyroid gland, which has metabolic and/or cardiovascular effect 12. Known hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection or chronic liver disease 13. Kidney malfunction 14. Psychiatric disorders, epilepsy, risk of suicide 15. Drug or alcohol abuse 16. Intake of nitrate and/or calcium antagonists, which affect the blood pressure 17. Intake of drugs affecting the absorption, metabolism or excretion of food components or the gastro-intestinal motility 18. Intake of hormone preparations, particularly cortisone 19. Eating disorders, anorexia, bulimia, unusual outsider dietary habits 20. Legal incapacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial function (PAT-Index) after 56 (±2) days supplementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body mass index (BMI) 2. Waist circumference (WC) 3. Waist to hip ratio (WHR) 4. Blood pressure, pulse Changes in: 5. Fasting and postprandial triglycerides (AUC) 6. Fasting and postprandial insulin (AUC) 7. Fasting and postprandial glucose (AUC) 8. Homeostasis model assessment of insulin resistance (HOMA-IR) (insulin-glucose-product) 9. HOMA B-cell function 10. Metabolic regulatory parameters, namely: cholesteryl ester transfer protein (CETP), glutathione (GSH) 11. Lipids and apolipoproteins, namely total triglycerides and in very low density lipoprotein (VLDL)/triglyceride-rich lipoprotein (TRL), apoliprotein B100, total, low density lipoprotein (LDL) cholesterol and high density lipoprotein (HDL) cholesterol, free fatty acids, lipoprotein A (LpA) 12. Oxidative modification of lipids and oxidative stress, namely: oxidised LDL, isoprostanes 13. LDL- and CM/remnant-induced adhesion molecule expression on endothelial cells (human umbilical vein endothelial cells [HUVEC]) 14. Inflammatory parameters, namely: C-reactive protein (CRP), soluble VCAM (sVCAM), soluble ICAM (sICAM), soluble E-selectin, interleukin-6 (IL-6), TNFa, MCP-1 15. Gene expression profile in monocytes (fasting monocyte isolation), expression of genes which may affect antioxidative status, metabolism and inflammatory responses (arteriosclerosis) Measurements for the secondary outcome will be made after each intervention period. | — |
Countries
Germany
Outcome results
None listed