Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

Study Overview
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Brief Summary
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Grape seed proanthocyanidins have been reported to possess a hypotriglyceridemic effect after an acute or chronic consumption in rodents. In this study, we aimed to investigate the effects of an acute consumption of proanthocyanidins before a breakfast meal in humans. Moreover, the mechanisms implicated in the reduction of plasma triglycerides levels by grape seed proanthocyanidins in humans should be elucidated as well as its activity on vascular function.

Detailed Description
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The intervention will consist in the administration of 2 capsules containing the grape seed proanthocyanidins extract or 2 empty capsules (placebo) just before breakfast, which will consist of 100g of white bread, 75g of salami, 50g of fatty cheese, 125g of yogurt (10% fat), 25ml of olive oil and water ad libitum. The nutritional composition of this meal is as follows: 1.200 Kcal of energy content, 15% of energy from proteins, 22% from carbohydrates and 63% from fat (35% saturated fat), and 120mg of cholesterol. Blood samples will be taken at point 0.5,1,2,3 and 6 hours after breakfast. Moreover, urine samples will be collected at time 0 and 6 hours.

Official Title
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Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

Conditions
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Triglyceride Metabolism, Cardiovascular Function

Intervention / Treatment
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* Dietary Supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)
* Other: 2 empty capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the ages of 20 and 40 Signing the informed consent Exclusion Criteria: Body mass index (BMI) lower than 18.5 or greater than 27 Kg/m2 Smokers Regular medication Consumption of medication during the last week Following a weight-loss diet Vegetarians Abnormal glucose levels Diabetes Cardiovascular disease Gastrointestinal disease Anemia Nuts allergy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Product 1<br>35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) | Dietary Supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)<br> <br> |
| Placebo Comparator: Control product<br>2 empty capsules | Other: 2 empty capsules<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of plasma triglycerides concentration |  | 0-180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 0-0.5-1-2-3-6 hours | 
| Endothelial function (assessed by ischemic reactive hyperemia) |  | 0-0.5-1-2-3-6 hours | 
| Blood lipid levels, markers of inflammation and oxidation |  | 0-0.5-1-2-3-6 hours | 
| Plasma levels of procyanidins metabolites |  | 0-0.5-1-2-3-6 hours | 
| Markers of cholesterol metabolism in PBMCs (mRNA and protein). |  | 0-0.5-1-2-3-6 hours | 
| Membrane lipid composition of erythrocytes and oxidation markers. |  | 0-0.5-1-2-3-6 hours | 
| Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine) |  | 0-6 hours |