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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Butter oil; Dietary Supplement: Cream

• Registration Number: NCT01767077
• Lead Sponsor: Uppsala University

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 Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-14
• Study Start: 2013-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butter oil	Butter oil	Daily intake of 40 g butter oil
Cream	Cream	Daily intake of 100 g cream (40%)

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism; 🇸🇪 Uppsala, Sweden