Contact information
Type
Scientific
Primary contact
Prof Juergen Schrezenmeir
ORCID ID
Contact details
Institute for Physiology and Biochemistry of Nutrition
Federal Reserach Centre for Nutrition and Food
Hermann-Weigmann-Str. 1
Kiel
24103
Germany
+49 (0)431 609 2220
juergen.schrezenmeir@bfel.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
EFOMS II
Study hypothesis
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
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).
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
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Functional milk-product (product code 966125, a non-registered product)
Primary outcome measures
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 trial start date
27/11/2007
Overall trial end date
30/07/2008
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
240 volunteers (120 for each the verum and control group)
Participant 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
Recruitment start date
27/11/2007
Recruitment end date
30/07/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Institute for Physiology and Biochemistry of Nutrition
Kiel
24103
Germany
Sponsor information
Organisation
Humana GmbH (Germany)
Sponsor details
Bielefelder Strasse 66
Herford
32051
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Humana GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary