Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans (MFGM)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Butter oil
Cream
Sponsored by
About this trial
This is an interventional basic science trial for Hypercholesterolemia focused on measuring Saturated fat, Dairy products, Milk fat globule membrane, Cholesterol, Butter, Cream
Eligibility 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
Sites / Locations
- Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Butter oil
Cream
Arm Description
Daily intake of 40 g butter oil
Daily intake of 100 g cream (40%)
Outcomes
Primary Outcome Measures
LDL-cholesterol
Secondary Outcome Measures
Other major blood lipids
HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins
Homeostasis model of assessment - insulin resistance
Insulin and glucose
Peripheral blood mononuclear cell gene expression
Inflammatory markers
C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist
Full Information
NCT ID
NCT01767077
First Posted
January 9, 2013
Last Updated
September 23, 2013
Sponsor
Uppsala University
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
1. Study Identification
Unique Protocol Identification Number
NCT01767077
Brief Title
Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Acronym
MFGM
Official Title
Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Saturated fat, Dairy products, Milk fat globule membrane, Cholesterol, Butter, Cream
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Butter oil
Arm Type
Placebo Comparator
Arm Description
Daily intake of 40 g butter oil
Arm Title
Cream
Arm Type
Active Comparator
Arm Description
Daily intake of 100 g cream (40%)
Intervention Type
Dietary Supplement
Intervention Name(s)
Butter oil
Intervention Description
Daily intake of 40 g butter oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Cream
Intervention Description
Daily intake of 100 g cream (40%)
Primary Outcome Measure Information:
Title
LDL-cholesterol
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Other major blood lipids
Description
HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins
Time Frame
8 weeks
Title
Homeostasis model of assessment - insulin resistance
Description
Insulin and glucose
Time Frame
8 weeks
Title
Peripheral blood mononuclear cell gene expression
Time Frame
8 weeks
Title
Inflammatory markers
Description
C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Risérus, Assoc prof
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26016870
Citation
Rosqvist F, Smedman A, Lindmark-Mansson H, Paulsson M, Petrus P, Straniero S, Rudling M, Dahlman I, Riserus 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.
Results Reference
derived
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Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
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