Pea Protein and Postprandial Response (PEA) (PEA)
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
High-fat shake with Pea protein
High-fat shake with Pea protein hydrolysate
High-fat shake - Control
High-fat shake with Gluten protein
High-fat shake with Gluten protein hydrolysate
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome
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
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
Sites / Locations
- Wageningen University, Division of Human Nutrition
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Satiety markers and Oxidative stress
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).
Full Information
NCT ID
NCT01215370
First Posted
September 30, 2010
Last Updated
September 6, 2011
Sponsor
Wageningen University
1. Study Identification
Unique Protocol Identification Number
NCT01215370
Brief Title
Pea Protein and Postprandial Response (PEA)
Acronym
PEA
Official Title
Effect of Arginine-rich Dietary Protein on Postprandial Metabolism, Inflammation and Endothelial Function
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wageningen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
High-fat shake with Pea protein
Other Intervention Name(s)
Experimental
Intervention Description
Shake containing 95 gram of fat, additive 30 gram pea protein
Intervention Type
Other
Intervention Name(s)
High-fat shake with Pea protein hydrolysate
Other Intervention Name(s)
Experimental
Intervention Description
Shake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate
Intervention Type
Other
Intervention Name(s)
High-fat shake - Control
Other Intervention Name(s)
Control
Intervention Description
Shake containing 95 gram of fat, no protein additive
Intervention Type
Other
Intervention Name(s)
High-fat shake with Gluten protein
Other Intervention Name(s)
Experimental
Intervention Description
Shake containing 95 gram of fat, additive 30 gram gluten protein.
Intervention Type
Other
Intervention Name(s)
High-fat shake with Gluten protein hydrolysate
Other Intervention Name(s)
Experimental
Intervention Description
Shake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate
Primary Outcome Measure Information:
Title
Postprandial metabolic, inflammatory and endothelial response
Description
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).
Time Frame
up to 6 hours
Secondary Outcome Measure Information:
Title
Satiety markers and Oxidative stress
Description
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).
Time Frame
up to 6 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Mensink, Dr
Organizational Affiliation
Department Human Nutrition, Wageningen University
Official's Role
Study Chair
Facility Information:
Facility Name
Wageningen University, Division of Human Nutrition
City
Wageningen
State/Province
Gelderland
Country
Netherlands
12. IPD Sharing Statement
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Pea Protein and Postprandial Response (PEA)
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