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OpenTrials
Completed

NCT Number: NCT01767077

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

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).

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Uppsala, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butter oil

Dietary Supplement

Daily intake of 40 g butter oil

Cream

Dietary Supplement

Daily intake of 100 g cream (40%)

Primary outcomes

  1. LDL-cholesterol

    Time frame: 8 weeks

Secondary outcomes

  1. Other major blood lipids

    Time frame: 8 weeks

    HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins

  2. Homeostasis model of assessment - insulin resistance

    Time frame: 8 weeks

    Insulin and glucose

  3. Peripheral blood mononuclear cell gene expression

    Time frame: 8 weeks

  4. Inflammatory markers

    Time frame: 8 weeks

    C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Arla Foods
  • LRF Mjölk, Sweden
  • Livsmedelsföretagen, Sweden
  • Lund University
  • Semper AB, Sweden
  • Skånemejerier, Sweden
  • Svensk Dagligvaruhandel, Sweden
  • Swedish Nutrition Foundation SNF
  • The Swedish Farmers' Foundation for Agricultural Research
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
  • Vinnova

Registry information

Acronym: MFGM

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 14, 2013
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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