ISRCTN41474531
Completed
Not Applicable
Randomised, controlled, double-blind clinical study on the effect of a functional milk-product on metabolism of men with diagnosed metabolic syndrome
Humana GmbH (Germany)0 sites60 target enrollmentApril 30, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Humana GmbH (Germany)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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