Triglyceride MetabolismNCT01688154
Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
A study testing 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) and 2 empty capsules in people with Triglyceride Metabolism and Cardiovascular Function, run by Technological Centre of Nutrition and Health, Spain at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Triglyceride Metabolism, Cardiovascular Function
- What is being tested?
- 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) and 2 empty capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between the ages of 20 and 40
- Signing the informed consent
Who cannot join
- 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
Show all 12Show fewer
- Abnormal glucose levels
- Diabetes
- Cardiovascular disease
- Gastrointestinal disease
- Anemia
- Nuts allergy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
CTNS
Reus, Tarragona, 43204
Technological Center of Nutrition and Health (CTNS)
Reus, Tarragona, 43204
About this study
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.
Read the 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.
- Conditions
- Triglyceride Metabolism, Cardiovascular Function
- Being tested
- 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules), 2 empty capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)Dietary supplement
2 empty capsulesOther
| Study group | Role | What they receive |
|---|---|---|
| Product 1 | Active comparator | 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) Receives: Dietary Supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) |
| Control product | Placebo comparator | 2 empty capsules Receives: Other: 2 empty capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of plasma triglycerides concentration
Measured: 0-180 minutes
Secondary outcomes (7)
Blood pressure
Measured: 0-0.5-1-2-3-6 hours
Endothelial function (assessed by ischemic reactive hyperemia)
Measured: 0-0.5-1-2-3-6 hours
Blood lipid levels, markers of inflammation and oxidation
Measured: 0-0.5-1-2-3-6 hours
Plasma levels of procyanidins metabolites
Measured: 0-0.5-1-2-3-6 hours
Markers of cholesterol metabolism in PBMCs (mRNA and protein).
Measured: 0-0.5-1-2-3-6 hours
Membrane lipid composition of erythrocytes and oxidation markers.
Measured: 0-0.5-1-2-3-6 hours
Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine)
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triglyceride MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- University Rovira i Virgili, Hospital Universitari Sant Joan de Reus
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, PhD, Principal investigator, University Rovira i VirgiliMaria Cinta Bladé, PhD, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688154
- Sponsor's protocol ID
- 306724
- Status last verified
- Jul 2013
- First submitted
- 14 Sep 2012
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Grape Seed Proanthocyanidins to Reduce Postprandial Triglycerides in Humans
- ClinicalTrials.gov ID
- NCT01688154
- Acronym / sponsor ID
- 306724
- Conditions
- Triglyceride Metabolism, Cardiovascular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Collaborators
- University Rovira i Virgili, Hospital Universitari Sant Joan de Reus
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product 1 | Active comparator | Dietary Supplement: 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) |
| Control product | Placebo comparator | Other: 2 empty capsules2 empty capsules |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults between the ages of 20 and 40
- Signing the informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) | Dietary supplement | Product 1 |
| 2 empty capsules | Other | Control product |
Primary outcome
Area under the curve of plasma triglycerides concentration
Time frame: 0-180 minutes
7 secondary outcomes
Blood pressure
Time frame: 0-0.5-1-2-3-6 hours
Endothelial function (assessed by ischemic reactive hyperemia)
Time frame: 0-0.5-1-2-3-6 hours
Blood lipid levels, markers of inflammation and oxidation
Time frame: 0-0.5-1-2-3-6 hours
Plasma levels of procyanidins metabolites
Time frame: 0-0.5-1-2-3-6 hours
Markers of cholesterol metabolism in PBMCs (mRNA and protein).
Time frame: 0-0.5-1-2-3-6 hours
Membrane lipid composition of erythrocytes and oxidation markers.
Time frame: 0-0.5-1-2-3-6 hours
Non-targeted metabolomics and 8-epi-prostaglandin-F2α levels (in urine)
Time frame: 0-6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Solà, PhD principal investigator
University Rovira i Virgili
Maria Cinta Bladé, PhD principal investigator
University Rovira i Virgili
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 35 mg/Kg of grape seed proanthocyanidins extract (2 capsules) and 2 empty capsules in people with Triglyceride Metabolism and Cardiovascular Function, run by Technological Centre of Nutrition and Health, Spain at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of plasma triglycerides concentration (time frame: 0-180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.