Cardiovascular Function Clinical Trial
Official title:
Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Spain | CTNS | Reus | Tarragona |
Spain | Technological Center of Nutrition and Health (CTNS) | Reus | Tarragona |
Lead Sponsor | Collaborator |
---|---|
Technological Centre of Nutrition and Health, Spain | Hospital Universitari Sant Joan de Reus, University Rovira i Virgili |
Spain,
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 |
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