Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Function; Triglyceride Metabolism
• Intervention / Treatment: Dietary supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules); Other: 2 empty capsules

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Technological Center of Nutrition and Health (CTNS)
    • Reus, Tarragona, Spain, 43204
      • CTNS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Product 1; 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)	Dietary supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)
PLACEBO_COMPARATOR: Control product; 2 empty capsules	Other: 2 empty capsules

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Technological Centre of Nutrition and Health, Spain
• Collaborators: University Rovira i Virgili; Hospital Universitari Sant Joan de Reus
• Investigators: Principal Investigator: Rosa Solà, PhD, University Rovira i Virgili; Principal Investigator: Maria Cinta Bladé, PhD, University Rovira i Virgili

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: September 14, 2012
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (ESTIMATE): September 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 3, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Protective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Proanthocyanidin; Procyanidin
• Other Study ID Numbers: 306724