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

Hypercholesterolemia Clinical Trial

— MFGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767077
• Other study ID #: TvärLivs-MFGM
• Status: Completed
• Phase: N/A
• First received: January 9, 2013
• Last updated: September 23, 2013
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Butter oil
Daily intake of 40 g butter oil
• Cream
Daily intake of 100 g cream (40%)

Locations

Country	Name	City	State
Sweden	Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism	Uppsala

Sponsors (12)

Lead Sponsor	Collaborator
Uppsala University	Arla Foods, Livsmedelsföretagen, Sweden, LRF Mjölk, 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

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol		8 weeks	No
Secondary	Other major blood lipids	HDL-cholesterol, total cholesterol, triglycerides, apolipoproteins	8 weeks	No
Secondary	Homeostasis model of assessment - insulin resistance	Insulin and glucose	8 weeks	No
Secondary	Peripheral blood mononuclear cell gene expression		8 weeks	No
Secondary	Inflammatory markers	C-reactive protein, Tumor necrosis factor alfa receptor 2, Interleukin-1-receptor antagonist	8 weeks	No