Pea Protein and Postprandial Response (PEA)

NCT ID: NCT01215370

Last Updated: 2011-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-01-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Interventions

High-fat shake with Pea protein

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

Intervention Type: OTHER

High-fat shake with Pea protein hydrolysate

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

Intervention Type: OTHER

High-fat shake - Control

Shake containing 95 gram of fat, no protein additive

Intervention Type: OTHER

High-fat shake with Gluten protein

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

Intervention Type: OTHER

High-fat shake with Gluten protein hydrolysate

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

Intervention Type: OTHER

Other Intervention Names

Experimental; Experimental; Control; Experimental; Experimental

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Wageningen University

Principal Investigators

Marco Mensink, Dr

Role: STUDY_CHAIR

Department Human Nutrition, Wageningen University

Locations

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL3207808110

Identifier Type: OTHER

Identifier Source: secondary_id