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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Arla Foods | INDUSTRY |
| Wageningen University | OTHER |
| University of Dublin, Trinity College |
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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.
See above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat rich in MC-SFA | Experimental | 63 gram milk fat with high content of MC-SFA (C6-C12=8.5 g) incorporated in rolls, muffin and as butter. |
|
| Fat low on MC-SFA | Experimental | 63 gram milkfat with low content of MC-SFA (C6-C12=6.9 g) incorporated in rolls, muffin and as butter |
|
| Casein protein | Experimental | 60 gram casein protein (Miprodan 30) ingested twice daily with 600 ml water. |
|
| Whey protein | Experimental | 60 gram whey protein (Lacprodan DI-9224) ingested twice daily with 600 ml water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High content of MC-SFA | Dietary Supplement | 12 weeks dietary intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial triglyceride response | 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. | Change from week 0 to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour blood pressure (BP) | Spacelabs, model 90207/90217, USA | Change from week 0 to week 12 |
| Indirect calorimetry | Measured 2 times during meal test. |
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Inclusion Criteria:
Metabolic syndrome
Or abdominal obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjeld Hermansen, Professor | Aarhus University Hospital | Principal Investigator |
| Hanne C Bertram, Scientist | Department of Food Science, University of Aarhus | Study Chair |
| Lorraine O'Driscoll, Professor | School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin, Ireland | Study Chair |
| Michael Müller, Professor | Division of Human Nutrition, Wageningen University, The Netherlands | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25833983 | Derived | Bohl M, Bjornshave A, Rasmussen KV, Schioldan AG, Amer B, Larsen MK, Dalsgaard TK, Holst JJ, Herrmann A, O'Neill S, O'Driscoll L, Afman L, Jensen E, Christensen MM, Gregersen S, Hermansen K. Dairy proteins, dairy lipids, and postprandial lipemia in persons with abdominal obesity (DairyHealth): a 12-wk, randomized, parallel-controlled, double-blinded, diet intervention study. Am J Clin Nutr. 2015 Apr;101(4):870-8. doi: 10.3945/ajcn.114.097923. Epub 2015 Jan 14. |
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No plan to share data
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067796 | Whey |
| D002364 | Caseins |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| OTHER |
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| Whey |
| Dietary Supplement |
12 weeks dietary intervention |
|
| Low content of MC-SFA | Dietary Supplement | 12 weeks dietary intervention |
|
| Casein | Dietary Supplement | 12 weeks dietary intervention |
|
| Change from week 0 to week 12 |
| Dexa-scan (body composition) | Total body fat percentage, lean mass, gynoid, and android fat percentage, and total body weight. | Change from week 0 to week 12 |
| Weight | Change from week 0 to week 12 |
| Biomarkers in blood samples | 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. | Change from week 0 to week 12 |
| Waist and hip circumference | Change from week 0 to week 12 |
| Fat tissue biopsy | Fat tissue gene expression. Twice during meal test. | Change from week 0 to week 12 |
| Biomarkers in urine | Nutrigenomics and metabolomics | Change from week 0 to week 12 |
| Glucose tolerance | 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. | Change from week 0 to week 12 |
| Dietary compliance | 3-day food diary. | Change from week 0 to week 12 |
| Postprandial apolipoprotein-48 (apoB-48), 6 hour | Meal test, blood samples at time 0,2,4 and 6 hours. | Change from week 0 to week 12 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010750 | Phosphoproteins |