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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Butter oil
* Dietary Supplement: Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Butter oil<br>Daily intake of 40 g butter oil | Dietary Supplement: Butter oil<br>* Daily intake of 40 g butter oil<br>|
| Active Comparator: Cream<br>Daily intake of 100 g cream (40%) | Dietary Supplement: Cream<br>* Daily intake of 100 g cream (40%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other major blood lipids | HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins | 8 weeks | 
| Homeostasis model of assessment - insulin resistance | Insulin and glucose | 8 weeks | 
| Peripheral blood mononuclear cell gene expression |  | 8 weeks | 
| Inflammatory markers | C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saturated fat, Dairy products, Milk fat globule membrane, Cholesterol, Butter, Cream