Metabolic Syndrome
Conditions
Brief summary
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
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.
Interventions
OTHERHigh-fat shake with Pea protein
Shake containing 95 gram of fat, additive 30 gram pea protein
OTHERHigh-fat shake with Pea protein hydrolysate
Shake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate
OTHERHigh-fat shake - Control
Shake containing 95 gram of fat, no protein additive
OTHERHigh-fat shake with Gluten protein
Shake containing 95 gram of fat, additive 30 gram gluten protein.
OTHERHigh-fat shake with Gluten protein hydrolysate
Shake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate
Sponsors
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial metabolic, inflammatory and endothelial response | up to 6 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety markers and Oxidative stress | up to 6 hours | 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). |
Countries
Netherlands
Outcome results
None listed