MedDataX Logo

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

NCT ID: NCT01767077

Last Updated: 2013-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Saturated fat Dairy products Milk fat globule membrane Cholesterol Butter Cream

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Butter oil

Daily intake of 40 g butter oil

Group Type PLACEBO_COMPARATOR

Butter oil

Intervention Type DIETARY_SUPPLEMENT

Daily intake of 40 g butter oil

Cream

Daily intake of 100 g cream (40%)

Group Type ACTIVE_COMPARATOR

Cream

Intervention Type DIETARY_SUPPLEMENT

Daily intake of 100 g cream (40%)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Butter oil

Daily intake of 40 g butter oil

Intervention Type DIETARY_SUPPLEMENT

Cream

Daily intake of 100 g cream (40%)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lund University

OTHER

Sponsor Role collaborator

LRF Mjölk, Sweden

UNKNOWN

Sponsor Role collaborator

Arla Foods

INDUSTRY

Sponsor Role collaborator

Skånemejerier, Sweden

UNKNOWN

Sponsor Role collaborator

Semper AB, Sweden

UNKNOWN

Sponsor Role collaborator

The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

OTHER_GOV

Sponsor Role collaborator

Swedish Nutrition Foundation SNF

UNKNOWN

Sponsor Role collaborator

Vinnova

OTHER_GOV

Sponsor Role collaborator

The Swedish Farmers' Foundation for Agricultural Research

UNKNOWN

Sponsor Role collaborator

Livsmedelsföretagen, Sweden

UNKNOWN

Sponsor Role collaborator

Svensk Dagligvaruhandel, Sweden

UNKNOWN

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ulf Risérus, Assoc prof

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Rosqvist F, Smedman A, Lindmark-Mansson H, Paulsson M, Petrus P, Straniero S, Rudling M, Dahlman I, Riserus U. Potential role of milk fat globule membrane in modulating plasma lipoproteins, gene expression, and cholesterol metabolism in humans: a randomized study. Am J Clin Nutr. 2015 Jul;102(1):20-30. doi: 10.3945/ajcn.115.107045. Epub 2015 May 27.

Reference Type DERIVED
PMID: 26016870 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TvärLivs-MFGM

Identifier Type: -

Identifier Source: org_study_id