Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
MFGM
1 other identifier
interventional
52
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 25, 2013
September 1, 2013
4 months
January 9, 2013
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-cholesterol
8 weeks
Secondary Outcomes (4)
Other major blood lipids
8 weeks
Homeostasis model of assessment - insulin resistance
8 weeks
Peripheral blood mononuclear cell gene expression
8 weeks
Inflammatory markers
8 weeks
Study Arms (2)
Butter oil
PLACEBO COMPARATORDaily intake of 40 g butter oil
Cream
ACTIVE COMPARATORDaily intake of 100 g cream (40%)
Interventions
Eligibility Criteria
You may qualify if:
- BMI 25-37
- LDL-cholesterol 2.0-4.5 mmol/l
You may not qualify if:
- Use of lipid lowering drugs
- Diagnosed cardiovascular disease or diabetes
- Use of extreme diets
- Food allergies relevant to the study
- Pregnancy or active lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Lund Universitycollaborator
- LRF Mjölk, Swedencollaborator
- Arla Foodscollaborator
- Skånemejerier, Swedencollaborator
- Semper AB, Swedencollaborator
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)collaborator
- Swedish Nutrition Foundation SNFcollaborator
- Vinnovacollaborator
- The Swedish Farmers' Foundation for Agricultural Researchcollaborator
- Livsmedelsföretagen, Swedencollaborator
- Svensk Dagligvaruhandel, Swedencollaborator
Study Sites (1)
Uppsala university, Dept of public health and caring sciences; Clinical nutrition and metabolism
Uppsala, Sweden
Related Publications (1)
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.
PMID: 26016870DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulf Risérus, Assoc prof
Uppsala University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2013
First Posted
January 14, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 25, 2013
Record last verified: 2013-09