Effect of Functional milk product On the Metabolic Syndrome II
| ISRCTN | ISRCTN90960030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90960030 |
| Protocol serial number | N/A |
| Sponsor | Humana GmbH (Germany) |
| Funder | Humana GmbH (Germany) |
- Submission date
- 18/12/2007
- Registration date
- 05/02/2008
- Last edited
- 05/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Juergen Schrezenmeir
Scientific
Scientific
Institute for Physiology and Biochemistry of Nutrition
Federal Reserach Centre for Nutrition and Food
Hermann-Weigmann-Str. 1
Kiel
24103
Germany
| Phone | +49 (0)431 609 2220 |
|---|---|
| juergen.schrezenmeir@bfel.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | The study is a randomised double-blind placebo-controlled intervention study over 8 weeks. |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study acronym | EFOMS II |
| Study objectives | The goal of the investigation is the question, to what extent the risk of the metabolic syndrome may be reduced by substances naturally occurring in milk. The pathophysiology of the metabolic syndrome is characterised by an insulin resistance, a dyslipidaemia, an essential hypertension and adiposity of the central type and frequently leads to early manifestation of type 2 diabetes mellitus and atherosclerosis. Such metabolic disturbances increase in the industrialised countries and in the developing countries, too, and represent an important economical and public-health cost factor. It is necessary to identify the relevant factors of human nutrition and to develop potential avoidance strategies, e.g. by development of functional food. The cow-milk derived substances, which will be used in this study have had influenced individual components of the metabolic syndrome and lowered the risk of components of the metabolic syndrome in own animal and human trials. This study is an extension of a previous human study (ISRCTN41474531 - see http://www.controlled-trials.com/ISRCTN41474531). |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of the Medical Faculty of the Christian-Albrechts-University of Kiel (Germany) on the 26th October 2007 (ref: A171/06 - extended sample size). |
| Health condition(s) or problem(s) studied | Metabolic syndrome |
| Intervention | 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 the control group is based on meat protein and is isoenergetic and isonitrogenous. Primary and secondary outcome measures will be analysed before and at the end of the intervention. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Functional milk-product (product code 966125, a non-registered product) |
| Primary outcome measure(s) |
Change of HOMeostasis model Assessment of Insulin Resistance (HOMA-IR) during the intervention period. |
| Key secondary outcome measure(s) |
1. Blood pressure |
| Completion date | 30/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 240 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 27/11/2007 |
| Date of final enrolment | 30/07/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Institute for Physiology and Biochemistry of Nutrition
Kiel
24103
Germany
24103
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
