Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/12/2007
Date assigned
05/02/2008
Last edited
05/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.humana.de

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

Publication citations

Additional files

Editorial Notes