Pea Protein and Postprandial Response (PEA)

Study Overview
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Brief Summary
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The main objective is to investigate the postprandial effect of arginine-rich protein (i.e. pea-protein) on metabolic control, inflammation and endothelial function after a high-fat meal in subjects with characteristics of the metabolic syndrome.

Detailed Description
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Arginine is potential interesting considering the metabolic syndrome. Studies so far indicated both long-term effects, as well as acute - postprandial - actions; especially when metabolism is already challenged, e.g. in diabetic patients or after a high-fat meal. If arginine-rich proteins are equally effective is not known. Therefore we are interested in the effect of (arginine rich) protein on postprandial (dys)metabolism, inflammation and endothelial function, within 6 hours after a meal.

Official Title
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Effect of Arginine-rich Dietary Protein on Postprandial Metabolism, Inflammation and Endothelial Function

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: High-fat shake with Pea protein
* Other: High-fat shake with Pea protein hydrolysate
* Other: High-fat shake - Control
* Other: High-fat shake with Gluten protein
* Other: High-fat shake with Gluten protein hydrolysate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male gender central obesity: waist circumference ≥94 cm plus any one of the following four factors: raised triglyceride level: ≥1.7 mmol/L; reduced high-density lipoprotein (HDL) cholesterol: <1.03 mmol/L raised blood pressure: systolic blood pressure ≥130 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication raised fasting plasma glucose ≥ 5.6 mmol/L Additional inclusion criteria: age 45-70 years body weight should be stable for 3 months stable exercise habits during the last 6 months, and not participating in any vigorous exercise program Exclusion Criteria: tobacco smoking (undiagnosed) diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening active hearth disease, i.e. history of myocardial infarction or angina pectoris following, or have recently followed a (weight-loss) diet drug uses knowing to interfere with the objectives of the study oral corticosteroids, lipid-lowering drugs (statins) allergic to cow milk / dairy products or gluten vegetarians received inoculations within 2 months of starting or planned to during the study donated or intended to donate blood 2 months before till two months after the study abuse of drugs and/or alcohol participation in another biomedical study within 1 month before the first screening visit not agreeable to be informed about possible distorted blood values which could be found by screening

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: High-fat shake with Pea protein|Shake containing 95 gram of fat, additive 30 gram pea protein|
|Other: High-fat shake with Pea protein hydrolysate|Shake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate|
|Other: High-fat shake - Control|Shake containing 95 gram of fat, no protein additive|
|Other: High-fat shake with Gluten protein|Shake containing 95 gram of fat, additive 30 gram gluten protein.|
|Other: High-fat shake with Gluten protein hydrolysate|Shake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial metabolic, inflammatory and endothelial response | Metabolic: Plasma glucose, insulin and triglyceride levels (T= 0,1,2,3,4,5 and 6 hrs) Inflammatory: C-reactive protein (CRP), Plasminogen activator inhibitor-1 (PAI-1), Tumor necrosis factor-alpha (TNF-a), Interleukin-6 (IL-6), Inter-Cellular Adhesion Molecule-1 (ICAM-1) and Monocyte chemotactic protein-1 (MCP-1) (T=0, 2, 4 and 6 hrs). Endothelial function: Macro vascular regional arterial stiffness by Pulse Wave Analysis (PWA) (T=0, 3 and 6 hrs). | up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety markers and Oxidative stress | Satiety: Glucagon-like peptide-1 (GLP-1) (T=0,2,4 and 6 hrs). Oxidative stress: Peripheral blood mononuclear cells (PBMC) (T=0,3 and 6 hrs). | up to 6 hours |