Pea Protein and Postprandial Response (PEA)

Metabolic Syndrome Clinical Trial

— PEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215370
• Secondary ID: NL3207808110
• Status: Completed
• Phase: N/A
• First received: September 30, 2010
• Last updated: September 6, 2011
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No