Randomised, controlled, double-blind clinical study on the effect of a functional milk-product on metabolism of men with diagnosed metabolic syndrome
- Conditions
- Metabolic syndromeNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN41474531
- Lead Sponsor
- Humana GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method