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

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ClinicalTrials.gov Identifier: NCT01767077
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : September 25, 2013
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
The Swedish Farmers' Foundation for Agricultural Research
Livsmedelsföretagen, Sweden
Svensk Dagligvaruhandel, Sweden
Information provided by (Responsible Party):
Uppsala University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Butter oil Dietary Supplement: Cream Not Applicable

Detailed Description:
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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Butter oil
Daily intake of 40 g butter oil
 Dietary Supplement: Butter oil
Daily intake of 40 g butter oil
Active Comparator: Cream
Daily intake of 100 g cream (40%)
 Dietary Supplement: Cream
Daily intake of 100 g cream (40%)


Outcome Measures
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Primary Outcome Measures :
  1. LDL-cholesterol [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Other major blood lipids [ Time Frame: 8 weeks ]
    HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins

  2. Homeostasis model of assessment - insulin resistance [ Time Frame: 8 weeks ]
    Insulin and glucose

  3. Peripheral blood mononuclear cell gene expression [ Time Frame: 8 weeks ]
  4. Inflammatory markers [ Time Frame: 8 weeks ]
    C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767077


Locations
Sweden
Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism
Uppsala, Sweden
Sponsors and Collaborators
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
The Swedish Farmers' Foundation for Agricultural Research
Livsmedelsföretagen, Sweden
Svensk Dagligvaruhandel, Sweden
Investigators
Principal Investigator: Ulf Risérus, Assoc prof Uppsala University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01767077     History of Changes
Other Study ID Numbers: TvärLivs-MFGM
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

Keywords provided by Uppsala University:
Saturated fat
Dairy products
Milk fat globule membrane
 Cholesterol
Butter
Cream

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Milk fat globule
Anti-Infective Agents