Cardiovascular disease Circulatory System Complications and ill-defined descriptions of heart disease
Conditions
Interventions
Group 1: CLA 50:50 isomer mixture (cis9,trans11-CLA: trans10,cis12-CLA)
Group 2: safflower oil
Group 3: native olive oil
Group 4: safflower oil - thermally oxidised
Supplements given two times a day
Sponsors
Max Rubner Institute (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteers 2. Aged 45 - 68 years 3. Body mass index (BMI) 25 - 29 kg/m^2 4. Member of the Metabolic Intervention Cohort Kiel (MICK) 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 affects gastro-intestinal motility 5. Haemoglobin less than 12 g/dL 6. Latex allergy 7. Diabetes (fasting glucose levels greater than 125 mg/dl after repeated determination) 8. Surgery within the last 3 months, which still affects the current state of health 9. Intake of nitrate and/or calcium antagonists, which affect the blood pressure 10. Deformation of finger tips, which inhibits correct recording of EndoPAT (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 drugs affecting the absorption, metabolism or excretion of food components or the gastro-intestinal motility 17. Intake of hormone preparations, particularly cortisone 18. Eating disorders, anorexia, bulimia, unusual outsider dietary habits 19. Legal incapacity 20. Others depending on the judgement of the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in endothelial function: PAT-Index after 28(± 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. Lipids, namely total, low density lipoprotein (LDL-) and high density lipoprotein (HDL-) cholesterol 11. Oxidative modification of lipids and oxidative stress, namely: oxidised LDL, isoprostanes 13. Inflammatory parameters, namely: C-reactive protein (CRP), soluble vascular cell adhesion molecule (sVCAM), soluble intercellular adhesion molecule (sICAM), soluble E-selectin, interleukin-6 (IL-6), tumour necrosis factor alpha (TNF alpha), monocyte chemoattractant protein-1 (MCP-1) 14. Other regulators/hormones: adiponectin, leptin, ghrelin, glucagon-like peptide 1 (GLP-1), cholecystokinin (CCK), vascular endothelial growth factor (VEGF) All secondary parameters were determined both at start of the intervention (day 0) and end of the study, i.e. after 4 weeks. Treatment-induced changes were calculated and compared between intervention groups. | — |
Countries
Germany
Outcome results
None listed