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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 9, 2013
First Posted Date  ICMJE January 14, 2013
Last Update Posted Date September 25, 2013
Study Start Date  ICMJE February 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2013)
LDL-cholesterol [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
  • Other major blood lipids [ Time Frame: 8 weeks ]
    HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins
  • Homeostasis model of assessment - insulin resistance [ Time Frame: 8 weeks ]
    Insulin and glucose
  • Peripheral blood mononuclear cell gene expression [ Time Frame: 8 weeks ]
  • Inflammatory markers [ Time Frame: 8 weeks ]
    C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2013)
  • Other major blood lipids [ Time Frame: 8 weeks ]
    HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins
  • Homeostasis model of assessment - insulin resistance [ Time Frame: 8 weeks ]
    Insulin and glucose
  • Peripheral blood mononuclear cell gene expression [ Time Frame: 8 weeks ]
  • Inflammatory markers [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Official Title  ICMJE Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Butter oil
    Daily intake of 40 g butter oil
  • Dietary Supplement: Cream
    Daily intake of 100 g cream (40%)
Study Arms  ICMJE
  • 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
Publications * Rosqvist F, Smedman A, Lindmark-Månsson H, Paulsson M, Petrus P, Straniero S, Rudling M, Dahlman I, Risérus U. Potential role of milk fat globule membrane in modulating plasma lipoproteins, gene expression, and cholesterol metabolism in humans: a randomized study. Am J Clin Nutr. 2015 Jul;102(1):20-30. doi: 10.3945/ajcn.115.107045. Epub 2015 May 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2013)
52
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2013)
56
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01767077
Other Study ID Numbers  ICMJE TvärLivs-MFGM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Ulf Risérus, Assoc prof Uppsala University
PRS Account Uppsala University
Verification Date September 2013

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