Pea Protein and Postprandial Response (PEA)

NCT01215370 | Completed

• 1 other identifier: NL3207808110
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satiety markers and Oxidative stress

  up to 6 hours

Interventions

High-fat shake with Pea protein OTHER

Shake containing 95 gram of fat, additive 30 gram pea protein

Also known as: Experimental

High-fat shake with Pea protein hydrolysate OTHER

Shake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate

Also known as: Experimental

High-fat shake - Control OTHER

Shake containing 95 gram of fat, no protein additive

Also known as: Control

High-fat shake with Gluten protein OTHER

Shake containing 95 gram of fat, additive 30 gram gluten protein.

Also known as: Experimental

High-fat shake with Gluten protein hydrolysate OTHER

Shake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate

Also known as: Experimental

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Pea Proteins; Glutens

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Prolamins; Grain Proteins; Seed Storage Proteins

Study Officials

• Marco Mensink, Dr

  Department Human Nutrition, Wageningen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 6, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

NL (1)