Clinical trial NCT01688154: Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
Official title: Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Triglyceride Metabolism
Cardiovascular Function
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
Collaborators: name: University Rovira i Virgili
name: Hospital Universitari Sant Joan de Reus
First posted: 2012-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve of plasma triglycerides concentration
timeFrame: 0-180 minutes
Secondary outcomes:
measure: Blood pressure
timeFrame: 0-0.5-1-2-3-6 hours
measure: Endothelial function (assessed by ischemic reactive hyperemia)
timeFrame: 0-0.5-1-2-3-6 hours
measure: Blood lipid levels, markers of inflammation and oxidation
timeFrame: 0-0.5-1-2-3-6 hours
measure: Plasma levels of procyanidins metabolites
timeFrame: 0-0.5-1-2-3-6 hours
measure: Markers of cholesterol metabolism in PBMCs (mRNA and protein).
timeFrame: 0-0.5-1-2-3-6 hours
measure: Membrane lipid composition of erythrocytes and oxidation markers.
timeFrame: 0-0.5-1-2-3-6 hours
measure: Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine)
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: Reus
country: Spain
facility: CTNS
state: Tarragona
city: Reus
country: Spain
facility: Technological Center of Nutrition and Health (CTNS)
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili
name: Rosa Solà, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Rovira i Virgili
name: Maria Cinta Bladé, PhD
role: PRINCIPAL_INVESTIGATOR
References: