Status:
COMPLETED
Pea Protein and Postprandial Response (PEA)
Lead Sponsor:
Wageningen University
Conditions:
Metabolic Syndrome
Eligibility:
MALE
45-70 years
Phase:
NA
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 w...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01215370
Start Date
September 1 2010
End Date
January 1 2011
Last Update
September 7 2011
Active Locations (1)
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1
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, Netherlands