Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

Cardiovascular Function Clinical Trial

Official title:

Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688154
• Other study ID #: 306724
• Status: Completed
• Phase: N/A
• First received: September 14, 2012
• Last updated: July 2, 2013
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Technological Centre of Nutrition and Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Function
• Triglyceride Metabolism

Intervention

Dietary Supplement:
• 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)

Other:
• 2 empty capsules

Locations

Country	Name	City	State
Spain	CTNS	Reus	Tarragona
Spain	Technological Center of Nutrition and Health (CTNS)	Reus	Tarragona

Sponsors (3)

Lead Sponsor	Collaborator
Technological Centre of Nutrition and Health, Spain	Hospital Universitari Sant Joan de Reus, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of plasma triglycerides concentration		0-180 minutes	No
Secondary	Blood pressure		0-0.5-1-2-3-6 hours	No
Secondary	Endothelial function (assessed by ischemic reactive hyperemia)		0-0.5-1-2-3-6 hours	No
Secondary	Blood lipid levels, markers of inflammation and oxidation		0-0.5-1-2-3-6 hours	No
Secondary	Plasma levels of procyanidins metabolites		0-0.5-1-2-3-6 hours	No
Secondary	Markers of cholesterol metabolism in PBMCs (mRNA and protein).		0-0.5-1-2-3-6 hours	No
Secondary	Membrane lipid composition of erythrocytes and oxidation markers.		0-0.5-1-2-3-6 hours	No
Secondary	Non-targeted metabolomics and 8-epi-prostaglandin-F2a levels (in urine)		0-6 hours	No