Pea Protein and Postprandial Response (PEA)

Not Applicable

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT01215370
• Lead Sponsor: Wageningen University

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-06
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Wageningen University, Division of Human Nutrition; 🇳🇱 Wageningen, Gelderland, Netherlands