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

This study has been completed.
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: September 23, 2013
Last verified: September 2013
  Purpose

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 Intervention
Hypercholesterolemia
Dietary Supplement: Butter oil
Dietary Supplement: Cream

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • LDL-cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 52
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)

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).

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Sweden’s Innovation Agency
The Swedish Farmers' Foundation for Agricultural Research
Livsmedelsföretagen, Sweden
Svensk Dagligvaruhandel, Sweden
Investigators
Principal Investigator: Ulf Risérus, Assoc prof Uppsala University
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01767077     History of Changes
Other Study ID Numbers: TvärLivs-MFGM
Study First Received: January 9, 2013
Last Updated: September 23, 2013
Health Authority: Sweden: Regional Ethical Review Board

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014