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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01215370 |
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Date of registration:
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30/09/2010 |
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Primary sponsor: |
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Public title:
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Pea Protein and Postprandial Response (PEA)
PEA |
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Scientific title:
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Effect of Arginine-rich Dietary Protein on Postprandial Metabolism, Inflammation and Endothelial Function |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01215370 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Marco Mensink, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department Human Nutrition, Wageningen University |
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Key inclusion & exclusion criteria
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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
Age minimum:
45 Years
Age maximum:
70 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Metabolic Syndrome
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Intervention(s)
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Other: High-fat shake - Control
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Other: High-fat shake with Gluten protein
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Other: High-fat shake with Gluten protein hydrolysate
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Other: High-fat shake with Pea protein
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Other: High-fat shake with Pea protein hydrolysate
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Primary Outcome(s)
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Postprandial metabolic, inflammatory and endothelial response
[Time Frame: up to 6 hours]
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Secondary Outcome(s)
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Satiety markers and Oxidative stress
[Time Frame: up to 6 hours]
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Secondary ID(s)
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..
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NL3207808110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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