Aarhus University Hospital
Aarhus, Aarhus C, 8000, Denmark
NCT Number: NCT01472666
Dairy food contains a large amount of long-chain saturated fat, which traditionally has been linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and in particular whey proteins have been shown to have a beneficial effect on glucose disposal as well as anti-inflammatory properties. Therefore dairy products have a potential role in the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data from intervention studies are lacking.
Aims of this project is to explore and understand the influence on human health of both medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well as their interaction and potential positive synergy on the MeS.
The investigators hypothesize that whey protein and medium-chain saturated fatty acids improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory stress in humans and that they possess preventive effects on the risk of developing CVD and type 2 diabetes mellitus (T2DM).
A total of 64 people with MeS or abdominal obesity will be included. The design is a randomized double-blinded, controlled parallel diet-intervention trial.
Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA + whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to integrate the test foods in their habitual diet, which also continues unchanged. The subjects' energy intake is matched so they are kept weight stable throughout the study.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Aarhus, Aarhus C, 8000, Denmark
See above.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Metabolic syndrome
Or abdominal obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
Exclusion criteria
12 weeks dietary intervention
12 weeks dietary intervention
12 weeks dietary intervention
12 weeks dietary intervention
Time frame: Change from week 0 to week 12
Compare the changes in mean difference of 6 hours incremental area under the curve (iAUC) (week 12 - week 0) between the groups and the intervention components.
Time frame: Change from week 0 to week 12
Spacelabs, model 90207/90217, USA
Time frame: Change from week 0 to week 12
Measured 2 times during meal test.
Time frame: Change from week 0 to week 12
Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight.
Time frame: Change from week 0 to week 12
Time frame: Change from week 0 to week 12
Glucose, insulin, glucagon, HbA1c. free fatty acids, Lipid profile (total-cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride). Inflammations markers (interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-1 receptor antagonist (IL-1RA), interleukin-1 beta (IL-1b), high sensitive c-reactive protein (hs-CRP), adiponectin, monocyte chemoattractant protein-1 (MCP-1), Rantes (CCL5)). Incretins (GLP-1, GIP). Nutrigenomics. Metabolomics. Proteomics.
Time frame: Change from week 0 to week 12
Time frame: Change from week 0 to week 12
Fat tissue gene expression. Twice during meal test.
Time frame: Change from week 0 to week 12
Nutrigenomics and metabolomics
Time frame: Change from week 0 to week 12
Oral glucose tolerance test (OGTT) (with insulin and glucose measurement at time -15 min, -10 min, 0 min, 30 min, 60 min, and 120 min). Hereby calculating the homeostatic model assessment of insulin resistance (HOMA-IR) and the Matsuda index.
Time frame: Change from week 0 to week 12
3-day food diary.
Time frame: Change from week 0 to week 12
Meal test, blood samples at time 0,2,4 and 6 hours.
University of Aarhus
Other
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