Clinical trial NCT01215370: Pea Protein and Postprandial Response (PEA)
Official title: Effect of Arginine-rich Dietary Protein on Postprandial Metabolism, Inflammation and Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 18
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Postprandial metabolic, inflammatory and endothelial response
timeFrame: up to 6 hours
Secondary outcomes:
measure: Satiety markers and Oxidative stress
timeFrame: up to 6 hours
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
state: Gelderland
Study officials:
affiliation: Department Human Nutrition, Wageningen University
name: Marco Mensink, Dr
role: STUDY_CHAIR
References: