Not applicable Not Applicable Not applicable
Conditions
Interventions
All participants will consume, in random order, capsules with either the individual isomers cis9,trans11-CLA and trans10,cis12-CLA as well as the commercially available 50:50 mixture of these isomers,
Sponsors
Federal Research Centre for Nutrition and Food (BfEL) (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteers aged 45-68 2. Homozygosis of PPAR?2 P12A polymorphism 3. Member of the Metabolic Intervention Cohort Kiel (MICK) BMI- matched controls will be recruited.
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. Hemoglobin 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 and/or alpha-blockers, which affect the blood pressure 10. Deformation of finger tips, which inhibits correct recording of EndoPAT 11. Illness of thyroid gland, which has metabolic and/or cardiovascular effect 12. Known hepatitis B, hepatitis C, HIV infection or chronic liver damage 13. Kidney insufficiency 14. Drug or alcohol abuse 15. Intake of drugs affecting the absorption, metabolism or excretion of food components or the gastro-intestinal motility 16. Intake of hormone preparations, particularly cortisone 17. Eating disorders, anorexia, bulimia, unusual outsider dietary habits 18. Psychiatric disorders, epilepsy, risk of suicide 19. For those who participate in adipose tissue biopsy, additionally: 19.1. Known allergies against local anaesthetics 19.2. Heart insufficiency 19.3. Coagulation dysfunction/consumption of drugs which may cause such dysfunctions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of postprandial triglyceride levels (Area Under the Curve [AUC]) after 28 (±2) days supplementation. Postprandial triglyceride levels will be measured at the start of the study and after each intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurements for the following will be made at the start of the study and after each intervention period. Changes in: 1. Fasting and postprandial insulin (AUC) 2. Fasting and postprandial glucose (AUC) 3. Endothelial function (PAT-Index) 4. Body Mass Index (BMI) 5. Waist circumference (WC) 6. Waist to hip ratio (WHR) 7. Blood pressure, pulse 8. HOMA (Insulin-glucose-product) 9. Metabolic regulatory parameters, namely: 9.1. Glucose dependent insulinotropic polypeptide (GIP) 9.2. Adipsinresistin 9.3. Cholesteryl Ester Transfer Protein (CETP) 9.4. Adiponectin 9.5. Leptin 9.6. Cholezystokinin (CCK) 9.7. Acylation Stimulating Protein (ASP) 10.1. Lipids and apolipoproteins, namely: 10.2. VLDL, total 10.3. LDL- and HDL-cholesterol 10.4. Lipoprotein a (Lp [a]) 10.5 Lipoprotein lipase (LpL) 10.6. Apoliprotein AI, AII, and B100 10.7. Fatty acid pattern in cholesteryl esters 10.8. Phospholipids 11. Oxidative modification of lipids and oxidative stress, namely: 11.1. Oxidised LDL 11.2. isoprostanes 11.3. LDL-induced adhesion molecule expression 11.4. Platelet-Activating Factor (PAF) 11.5. total glutathione in erythrocytes,paraoxonase 11.6. Platelet-Activating Factor AcetylHydrolase (PAF-AH) 12. Inflammatory parameters, namely: 12.1. C-reactive protein (CRP) 12.2. Vascular Cell Adhesion Molecule (VCAM) 12.3. InterCellular Adhesion Molecule (ICAM) 12.4. E-selectin, InterLeukin-6 (IL-6) 12.5. Tumor Necrosis Factor-a (TNFa) 12.6. Monocyte Chemoattractant Protein-1 (MCP-1) 12.7. Vascular Endothelial Growth Factor (VEGF) 13. Gene expression profile in adipocytes (fasting adipocyte biopsy) and monocytes (fasting monocyte isolation) by Random-Zell-RNA-assay: expression of genes which may affect lipid metabolism and inflammatory responses (arteriosclerosis) 14. Fecal flora | — |
Countries
Germany
Outcome results
None listed