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Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans (MFGM)

This study is not yet open for participant recruitment.
Verified February 2013 by Uppsala University
Sponsor:
Collaborators:
Lund University
LRF Mjölk, Sweden
Arla Foods
Skånemejerier, Sweden
Semper AB, Sweden
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Swedish Nutrition Foundation SNF
VINNOVA Sweden’s Innovation Agency
The Swedish Farmers' Foundation for Agricultural Research
Livsmedelsföretagen, Sweden
Svensk Dagligvaruhandel, Sweden
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01767077
First received: January 9, 2013
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

January 9, 2013
February 5, 2013
February 2013
June 2013   (final data collection date for primary outcome measure)
LDL-cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01767077 on ClinicalTrials.gov Archive Site
  • Other major blood lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins
  • Homeostasis model of assessment - insulin resistance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Insulin and glucose
  • Peripheral blood mononuclear cell gene expression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist
  • Other major blood lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins
  • Homeostasis model of assessment - insulin resistance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Insulin and glucose
  • Peripheral blood mononuclear cell gene expression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans

Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).

Dairy foods are a major component of the nordic diet. Epidemiological data suggest potential health effects of dairy foods with regard to obesity related disorders. Low-fat dairy foods have shown to be protective, but also high-fat products have been linked to reduced risk in some studies. It is well known that dairy products increase LDL-cholesterol in blood, but effects on glucose metabolism are unclear. Intervention trials are needed to clarify the health effects of dairy foods. Some data have indicated that cheese and milk may have less hypercholesterolemic effect compared with butter. Our hypothesis is that milk fat globule membranes (MFGM), present in all dairy products except butter, can affect blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. Such idea might explain why different dairy products could have different effects on cholesterol levels. The investigators aim to conduct a controlled study to investigate this. Overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with MFGM).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Hypercholesterolemia
  • Dietary Supplement: Butter oil
    Daily intake of 40 g butter oil
  • Dietary Supplement: Cream
    Daily intake of 100 g cream (40%)
  • Placebo Comparator: Butter oil
    Daily intake of 40 g butter oil
    Intervention: Dietary Supplement: Butter oil
  • Active Comparator: Cream
    Daily intake of 100 g cream (40%)
    Intervention: Dietary Supplement: Cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
56
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI 25-37
  • LDL-cholesterol 2.0-4.5 mmol/l

Exclusion Criteria:

  • Use of lipid lowering drugs
  • Diagnosed cardiovascular disease or diabetes
  • Use of extreme diets
  • Food allergies relevant to the study
  • Pregnancy or active lactation
Both
20 Years to 70 Years
Yes
Contact: Ulf Risérus, Assoc prof 186117971 ext +46 ulf.riserus@pubcare.uu.se
Contact: Fredrik Rosqvist, PhD student 702781340 ext +46 fredrik.rosqvist@pubcare.uu.se
Sweden
 
NCT01767077
TvärLivs-MFGM
No
Uppsala University
Uppsala University
  • Lund University
  • LRF Mjölk, Sweden
  • Arla Foods
  • Skånemejerier, Sweden
  • Semper AB, Sweden
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
  • Swedish Nutrition Foundation SNF
  • VINNOVA Sweden’s Innovation Agency
  • The Swedish Farmers' Foundation for Agricultural Research
  • Livsmedelsföretagen, Sweden
  • Svensk Dagligvaruhandel, Sweden
Principal Investigator: Ulf Risérus, Assoc prof Uppsala University
Uppsala University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP