Effect of Functional milk product On the Metabolic Syndrome II

Randomised, controlled, double-blind clinical study on the effect of a functional milk-product on metabolism of men with diagnosed metabolic syndrome: study with extended sample size

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90960030

Enrollment

240

Registered

2008-02-05

Start date

2007-11-27

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome Nutritional, Metabolic, Endocrine Metabolic syndrome

Interventions

The volunteers of the verum group will take one portion of the functional milk-product (product code 966125, a non-registered product) once a day after lunch with a dessert for 56 days. The product of

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Secondary

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

Primary

Measure	Time frame
Change of HOMeostasis model Assessment of Insulin Resistance (HOMA-IR) during the intervention period.	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026