Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 4
- Primary Endpoint
- Area under the curve of plasma triglycerides concentration
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Regular medication
- •Consumption of medication during the last week
- •Following a weight-loss diet
- •Vegetarians
- •Abnormal glucose levels
- •Cardiovascular disease
- •Gastrointestinal disease
- •Nuts allergy
Outcomes
Primary Outcomes
Area under the curve of plasma triglycerides concentration
Time Frame: 0-180 minutes
Secondary Outcomes
- 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)