Endothelial DysfunctionPhase 1NCT02616822
Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients
A Phase 1 study testing Trans-resveratrol in people with Endothelial Dysfunction, run by Hospital Universitario Pedro Ernesto.
Trial summary
Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a major modifiable risk factors and one of the most important public health problems. Mortality from cardiovascular disease increases progressively with increasing blood pressure (BP) in a linear, continuous and independent. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Trans-resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Sep 2015
- Phase
- Phase 1
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients aged between 45 and 65 years, of both genders.
- Patients with a previous diagnosis of hypertension.
- Patients with endothelial disfunction.
- Stable use of antihypertensive treatment for at least 2 months.
- Patients with food consumption maintained for at least 4 weeks, oriented to limit the intake of foods rich in polyphenols, such as peanut butter, cranberry, blackberry, red grapes, red wine, green tea and chocolate.
- Signing the consent form.
Who cannot join
- Smoking.
- Diabetes Mellitus and / or use of insulin or oral hypoglycemic agents.
- Hormone replacement therapy.
- Use of ß-blockers and statins.
- Sleep apnea.
- Changes in thyroid function, chronic renal and liver diseases.
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- Clinically evident coronary heart disease with previous myocardial infarction and / or revascularization, with clinical signs of heart failure, cardiac arrhythmia, symptomatic or clinically significant valvular disease, prior stroke.
- History of drug or alcohol abuse. Presence of some kind of eating disorder;
- Diets restricted by choice (vegetarianism, carbohydrate restriction);
- Use of nutritional supplements (vitamins, minerals), to at least seven (7) days prior to the study;
- Patients who have any severe illness and life-threatening any condition, disease or therapy that, in the opinion of the investigator, may adversely affect the results, interfere with the study objectives or jeopardize the safety of patients.
About this study
Official title: Acute Effects Of Trans-Resveratrol in Endothelial Function in Treated Hypertensive Patients
Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a major modifiable risk factors and one of the most important public health problems. Mortality from cardiovascular disease increases progressively with increasing blood pressure (BP) in a linear, continuous and independent. The pathophysiological mechanisms involved in the pathogenesis of hypertension exhibit metabolic abnormalities, which are related to endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of plants, but in our food, mainly present in red wine and grapes, has shown protective effects in cardiovascular diseases, such as preventing the damage caused by oxidative stress, decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective effect of vascular endothelium, with increased release of nitric oxide and decreased production of free radicals in animal models, but human studies are limited and insufficient to clarify the possible effects of trans-resveratrol (biologically active form) on endothelial function, blood pressure and central aortic pressure in treated hypertensive individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol supplementation on endothelial function in treated hypertensive patients.
- Conditions
- Endothelial Dysfunction
- Being tested
- Trans-resveratrol, Placebo
- Keywords
- hypertension, endothelium, resveratrol, clinical trials
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-resveratrolDietary supplement
Used for trans-resveratrol substance 300 mg single dose
PlaceboOther
Used for placebo substance single dose
| Study group | Role | What they receive |
|---|---|---|
| trans-resveratrol | Experimental | Used for trans-resveratrol substance 300 mg single dose Receives: Dietary Supplement: Trans-resveratrol |
| Placebo | Placebo comparator | Used for placebo substance single dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilatation of the brachial artery
The patient lay comfortably in the supine position with slightly abducted right arm. After located the brachial artery, the transducer was placed on the anteromedial face of the right arm, perpendicular to the axis of the arm, 5-10 cm above the antecubital crease on the artery. The basal diameter of the brachial artery (BBAD) and post occlusion brachial artery diameter (POBAD) were measured manually between the intima-lumen interfaces at end-diastole. After BBAD, the site of contact of the probe was marked on the skin, so that the measurement of POBAD occur at the same site. The occlusion is maintained for five minutes through cuff on the arm, which print pressure slightly above the systolic blood pressure, confirmed by no pulse Doppler. The POBAD was measured 30, 60 and 90 seconds after releasing the flow. At baseline, after checking the criteria for inclusion and exclusion and signing the informed consent, the selected patient performs the DMF fasting and after 90 minutes.
Measured: 90 minutes
Secondary outcomes (1)
Determination of central aortic pressure (Sphygmocor)
Noninvasive test, conducted in peaceful environment, temperature controlled, patient lying supine, using his right arm to measure blood pressure and central aortic pressure.
The analysis of radial artery pulse wave by applanation tonometry is performed to derive central artery pressures and other hemodynamic parameters using Sphygmocor system (Atcor, USA). After measuring the BP in the brachial artery pulse wave of the radial artery on the same side were obtained for at least 10 seconds using a tonometer (SPC-301 - Millar Instruments, Houston, Texas), calibrated according to the brachial BP. The resulting radial pulse waves are processed using specific software (Sphygmocor v7 AtCor, USA) to derive the corresponding central aortic pressure through a previously validated transfer function. At baseline, after checking the criteria for inclusion and exclusion and signing the informed consent, the selected patient performs the SphymoCor fasting and after 90 minutes.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startJan 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianca Cristina Antunes Alves Marques, Hospital Universitario Pedro Ernesto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616822
- Sponsor's protocol ID
- Resv2013
- Status last verified
- Nov 2015
- First submitted
- 16 Oct 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects Of Trans-Resveratrol in Endothelial Function in Treated Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02616822
- Acronym / sponsor ID
- Resv2013
- Conditions
- Endothelial Dysfunction
- Keywords
- hypertension, endothelium, resveratrol, clinical trials
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Nov 2015 (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.
Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a major modifiable risk factors and one of the most important public health problems. Mortality from cardiovascular disease increases progressively with increasing blood pressure (BP) in a linear, continuous and independent. The pathophysiological mechanisms involved in the pathogenesis of hypertension exhibit metabolic abnormalities, which are related to endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of plants, but in our food, mainly present in red wine and grapes, has shown protective effects in cardiovascular diseases, such as preventing the damage caused by oxidative stress, decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective effect of vascular endothelium, with increased release of nitric oxide and decreased production of free radicals in animal models, but human studies are limited and insufficient to clarify the possible effects of trans-resveratrol (biologically active form) on endothelial function, blood pressure and central aortic pressure in treated hypertensive individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol supplementation on endothelial function in treated hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans-resveratrol | Experimental | Dietary Supplement: Trans-resveratrolUsed for trans-resveratrol substance 300 mg single dose |
| Placebo | Placebo comparator | Other: PlaceboUsed for placebo substance single dose |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients aged between 45 and 65 years, of both genders.
- Patients with a previous diagnosis of hypertension.
- Patients with endothelial disfunction.
- Stable use of antihypertensive treatment for at least 2 months.
- Patients with food consumption maintained for at least 4 weeks, oriented to limit the intake of foods rich in polyphenols, such as peanut butter, cranberry, blackberry, red grapes, red wine, green tea and chocolate.
Key exclusion criteria (11 listed)
- Smoking.
- Diabetes Mellitus and / or use of insulin or oral hypoglycemic agents.
- Hormone replacement therapy.
- Use of ß-blockers and statins.
- Sleep apnea.
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 |
|---|---|---|
| Trans-resveratrolUsed for trans-resveratrol substance 300 mg single dose | Dietary supplement | trans-resveratrol |
| PlaceboUsed for placebo substance single dose | Other | Placebo |
Primary outcome
Flow-mediated dilatation of the brachial artery
Time frame: 90 minutes
The patient lay comfortably in the supine position with slightly abducted right arm. After located the brachial artery, the transducer was placed on the anteromedial face of the right arm, perpendicular to the axis of the arm, 5-10 cm above the antecubital crease on the artery. The basal diameter of the brachial artery (BBAD) and post occlusion brachial artery diameter (POBAD) were measured manually between the intima-lumen interfaces at end-diastole. After BBAD, the site of contact of the probe was marked on the skin, so that the measurement of POBAD occur at the same site. The occlusion is maintained for five minutes through cuff on the arm, which print pressure slightly above the systolic blood pressure, confirmed by no pulse Doppler. The POBAD was measured 30, 60 and 90 seconds after releasing the flow. At baseline, after checking the criteria for inclusion and exclusion and signing the informed consent, the selected patient performs the DMF fasting and after 90 minutes.
1 secondary outcome
Determination of central aortic pressure (Sphygmocor)
Time frame: 90 minutes
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 30 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trans-resveratrol in people with Endothelial Dysfunction, run by Hospital Universitario Pedro Ernesto.
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 6 inclusion and 11 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Flow-mediated dilatation of the brachial artery (time frame: 90 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 30 Nov 2015.