Metabolic syndrome Nutritional, Metabolic, Endocrine Metabolic syndrome
Conditions
Sponsors
Humana GmbH (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: Men, 45-70 years old, with a metabolic syndrome as defined by the International Diabetes Federation, 2006 (A new IDF worldwide definition of the metabolic syndrome: the rationale and the results - Diabetes Voice, Vol. 50 Issue 3, 2005)
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. Intake of nitrate and/or calcium antagonists and/or alpha-blockers, which affect the blood pressure 3. Known metabolic or gastro-intestinal diseases, which affects the absorption, metabolism or excretion of food or food component 4. Condition after operation of the gastro-intestinal tract, which affect gastro-intestinal motility 5. Hemoglobin < 12 g/dL 6. Malfunction of blood coagulation or drugs, leading to malfunction of blood coagulating diabetes 7. Operation within the last 3 months, which still affects the current state of health 8. Illness of thyroid gland, which has metabolic and/or cardiovascular effect 9. Known hepatitis B, hepatitis C, HIV infection or chronic liver damage 10. Kidney insufficiency 11. Hypercalcaemia 12. Drug or alcohol abuse 13. Intake of drugs affecting the absorption, metabolism or excretion of food components or the gastro-intestinal 14. Intake of hormone preparations 15. Vegetarianism, anorexia, bulimia 16. Known milk protein allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of blood fructosamine concentration during the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Insulin sensitivity 2. Endothelial function 3. Blood pressure 4. Waist-to-hip ratio 5. Postprandial concentration of several hormones and blood parameters linked to fat and carbohydrate metabolism | — |
Countries
Germany
Outcome results
None listed