Pea Protein and Postprandial Response (PEA) (PEA)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands
      • Wageningen University, Division of Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wageningen University
• Investigators: Study Chair: Marco Mensink, Dr, Department Human Nutrition, Wageningen University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 30, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (Estimate): October 6, 2010

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: NL3207808110 (Other Identifier: Medical Ethics Review Committee)