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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01767077

Acronym

MFGM

Enrollment

Registered

2013-01-14

Start date

2013-02-28

Completion date

2013-06-30

Last updated

2013-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Saturated fat, Dairy products, Milk fat globule membrane, Cholesterol, Butter, Cream

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).

Interventions

DIETARY_SUPPLEMENTButter oil

Daily intake of 40 g butter oil

DIETARY_SUPPLEMENTCream

Daily intake of 100 g cream (40%)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
LDL-cholesterol	8 weeks

Secondary

Measure	Time frame	Description
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	—
Inflammatory markers	8 weeks	C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026