Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

Not Applicable

Completed

• Conditions: Triglyceride Metabolism; Cardiovascular Function
• Interventions: Dietary Supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules); Other: 2 empty capsules

• Registration Number: NCT01688154
• Lead Sponsor: Technological Centre of Nutrition and Health, Spain

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Study Start: 2013-02
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-02
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Product 1	35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)	35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)
Control product	2 empty capsules	2 empty capsules

Primary Outcome Measures

Name	Time	Method
Area under the curve of plasma triglycerides concentration	0-180 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

CTNS; 🇪🇸 Reus, Tarragona, Spain

Technological Center of Nutrition and Health (CTNS); 🇪🇸 Reus, Tarragona, Spain