Effect of Functional milk product On the Metabolic Syndrome II

ISRCTN	ISRCTN90960030
DOI	https://doi.org/10.1186/ISRCTN90960030
Secondary identifying numbers	N/A

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

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
Email	juergen.schrezenmeir@bfel.de

Study information

Study design	The study is a randomised double-blind placebo-controlled intervention study over 8 weeks.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Functional milk-product (product code 966125, a non-registered product)
Primary outcome measure	Change of HOMeostasis model Assessment of Insulin Resistance (HOMA-IR) during the intervention period.
Secondary outcome measures	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
Overall study start date	27/11/2007
Completion date	30/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	240 volunteers (120 for each the verum and control group)
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

Sponsor information

Humana GmbH (Germany)
Industry

Bielefelder Strasse 66
Herford
32051
Germany

Website	http://www.humana.de

Funders

Funder type

Industry

Humana GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan