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

September 23, 2013 updated by: Uppsala University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Butter oil
Daily intake of 40 g butter oil
Dietary supplement: Butter oil
Daily intake of 40 g butter oil
ACTIVE_COMPARATOR: Cream
Daily intake of 100 g cream (40%)
Dietary supplement: Cream
Daily intake of 100 g cream (40%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL-cholesterol
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

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

Investigators

  • Principal Investigator: Ulf Risérus, Assoc prof, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

January 9, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (ESTIMATE)

January 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TvärLivs-MFGM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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