Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 3, 2013
July 1, 2013
3 months
September 14, 2012
July 2, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the curve of plasma triglycerides concentration
0-180 minutes
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Product 1
ACTIVE COMPARATOR35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)
Control product
PLACEBO COMPARATOR2 empty capsules
Interventions
Eligibility Criteria
You may qualify if:
- Adults between the ages of 20 and 40
- Signing the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CTNS
Reus, Tarragona, 43204, Spain
Technological Center of Nutrition and Health (CTNS)
Reus, Tarragona, 43204, Spain
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Rosa Solà, PhD
University Rovira i Virgili
- PRINCIPAL INVESTIGATOR
Maria Cinta Bladé, PhD
University Rovira i Virgili
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 19, 2012
Study Start
February 1, 2013
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
July 3, 2013
Record last verified: 2013-07