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Completed

NCT Number: NCT01215370

Pea Protein and Postprandial Response (PEA)

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.

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Key information

Age range

45 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-fat shake with Pea protein

Other

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

Other names: Experimental

High-fat shake with Pea protein hydrolysate

Other

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

Other names: Experimental

High-fat shake - Control

Other

Shake containing 95 gram of fat, no protein additive

Other names: Control

High-fat shake with Gluten protein

Other

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

Other names: Experimental

High-fat shake with Gluten protein hydrolysate

Other

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

Other names: Experimental

Primary outcomes

  1. Postprandial metabolic, inflammatory and endothelial response

    Time frame: 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 outcomes

  1. Satiety markers and Oxidative stress

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

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

Acronym: PEA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2010
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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