Clinical trial NCT01767077: Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Official title: Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Saturated fat
Dairy products
Milk fat globule membrane
Cholesterol
Butter
Cream
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Lund University
name: LRF Mjölk, Sweden
name: Arla Foods
name: Skånemejerier, Sweden
name: Semper AB, Sweden
name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
name: Swedish Nutrition Foundation SNF
name: Vinnova
name: The Swedish Farmers' Foundation for Agricultural Research
name: Livsmedelsföretagen, Sweden
name: Svensk Dagligvaruhandel, Sweden
First posted: 2013-01-14
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: LDL-cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Other major blood lipids
timeFrame: 8 weeks
measure: Homeostasis model of assessment - insulin resistance
timeFrame: 8 weeks
measure: Peripheral blood mononuclear cell gene expression
timeFrame: 8 weeks
measure: Inflammatory markers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism
Study officials:
affiliation: Uppsala University
name: Ulf Risérus, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.