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The incidence of type 2 diabetes mellitus (T2DM) is rapidly growing. Patients with T2DM are at increased risk of developing long term micro- and macrovascular complications. Subjects with impaired glucose tolerance (IGT) show increased blood glucose levels after an oral glucose load. These subjects have a markedly increased risk of later T2DM development.
T2DM development can be prevented or delayed by lifestyle modifications. To support lifestyle changes and reduce the risk of T2DM development, foods containing functional ingredients are being developed. An interesting functional ingredient is protein hydrolysate. An egg protein hydrolysate has been experimentally shown to improve endothelial function, to inhibit plasma angiotensin converting enzyme (ACE) and to reduce blood pressure in rats. Egg protein hydrolysate could thus be a interesting ingredient to treat the cardiovascular dysfunction associated with T2DM. In the present study, the effects of egg protein hydrolysate will be evaluated in subjects with overweight or moderate obesity and IGT or T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention and placebo | Experimental | Once in the study, 20 subjects will be randomly assigned to a group taking capsules containing 5 gr egg protein hydrolysate per day, and 20 to a group taking placebo capsules. The subjects consume the capsules during three consecutive days (period 1). Following a wash-out period of minimally four weeks, the treatments are crossed-over. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protein hydrolysate capsules and placebo capsules | Dietary Supplement | Once in the study, 20 subjects will be randomly assigned to a group taking capsules containing 5 gr egg protein hydrolysate per day, and 20 to a group taking placebo capsules. The subjects consume the capsules during three consecutive days (period 1). Following a wash-out period of minimally four weeks, the treatments are crossed-over. |
| Measure | Description | Time Frame |
|---|---|---|
| The change (baseline vs 2 hours, and baseline vs 2 days) in arterial stiffness measured as carotid-femoral pulse wave velocity | baseline vs 2 hours, baseline vs 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glucose and insulin concentrations and calculated HOMA-index, incretins, lipids, characteristics of the microcirculation, and non-invasively assessed upper-arm blood pressure and central aortic systolic blood pressure and heart rate changes | baseline vs 2 hours, and baseline vs 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jogchum Plat, Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PreCare Trial & Recruitment | Beek | Limburg | 6191 JW | Netherlands |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011492 | Protein Hydrolysates |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |