Effect of Functional milk product On the Metabolic Syndrome II

Completed

• Conditions: Metabolic syndrome; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN90960030
• Lead Sponsor: Humana GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

1. Men, 45 - 70 years old
2. 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 components
4. Condition after operation of the gastro-intestinal tract, which affect gastro-intestinal motility
5. Haemoglobin less than 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 effects
9. Known hepatitis B, hepatitis C, human immunodeficiency virus (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 tract
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
Change of HOMeostasis model Assessment of Insulin Resistance (HOMA-IR) during the intervention period.

Secondary Outcome Measures

Name	Time	Method
1. Blood pressure <br>2. Body mass index (BMI), waist-to-hip ratio<br>3. Mean blood glucose during continuously glucose monitoring<br>4. Postprandial concentration of several hormones and blood parameters linked mainly to carbohydrate metabolism