Vascular System InjuriesNCT01668836
Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
A study testing Resveratrol and Caloric restriction in people with Vascular System Injuries and Lipid Metabolism Disorders, run by InCor Heart Institute at 1 site in Brazil.
Trial summary
Women have a natural protection that gives them greater longevity. One hypothesis most commonly used is the estrogen protection in the premenopausal period. However many studies of various forms of hormone replacement therapy proved ineffective in promoting additional protection for women. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular System Injuries, Lipid Metabolism Disorders, Endothelial Disfunction
- What is being tested?
- Resveratrol and Caloric restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical history, physical examination and electrocardiogram normal
Who cannot join
- premenopausal women (less than 1 year of natural amenorrhea)
- Body mass index ≥ 35 kg/m2
- Smoking
- Severe hypertension (diastolic blood pressure ≥ 110 mmHg)
- Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)
- Diabetes
- Previous using previous statins or hormone replacement therapy. Other exclusion criteria are: chronic renal failure (serum creatinine ≥ 2.0 mg / dl), hepatic, endocrine, hematologic, respiratory or metabolic clinically significant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years.
Women have a natural protection that gives them greater longevity. One hypothesis most commonly used is the estrogen protection in the premenopausal period. However many studies of various forms of hormone replacement therapy proved ineffective in promoting additional protection for women. Thus, it is discussed other ways of protection associated with longevity in women. Of these, the sirtuin system was found in several animal studies to be associated with longevity. This system also showed, through the involvement of several metabolic pathways, an important protection against the process of atherosclerosis. But the activity of this system in humans is unknown and if it is more active in women than in men. The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55 to 65 years, and their influence on the main metabolic pathways related to longevity and the process of atherosclerosis. The research protocol includes analysis of the influence of sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of inflammation and homeostasis, before and after the interventions with caloric restriction or resveratrol administration. It is expected of this study mechanistic conclusion for longevity and possible clinical applications in the mechanism of atherosclerosis prevention.
Read the detailed description
After a washout period of 15 days without medication, men and women will be randomized to the group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men) will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12 women and 12 men), a daily pill of 500mg of resveratrol. In the two moments, after the washout period and before the intervention (baseline) and after 30 days of intervention (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.
- Being tested
- Resveratrol, Caloric restriction
- Keywords
- sirtuin, atherosclerosis, longevity, calorie restriction, resveratrol, vascular reactivity
- Medical subject headings
- Vascular System Injuries, Lipid Metabolism Disorders, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
1 pill daily containing 500 mg/d of resveratrol for 30 days
Caloric restrictionBehavioural
Diet of 1000kcal per day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| men with resveratrol | Experimental | 12 men will receive a pill with 500mg of resveratrol daily for 30 days Receives: Drug: Resveratrol |
| women with resveratrol | Experimental | 12 women will receive a pill with 500mg of resveratrol daily for 30 days Receives: Drug: Resveratrol |
| men with caloric restriction | Active comparator | 12 men will follow a 1000 calories per day diet for 30 days Receives: Behavioral: Caloric restriction |
| women with caloric restriction | Active comparator | 12 women will follow a 1000 calories per day diet for 30 days Receives: Behavioral: Caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Evaluation of the Sirtuin 1 Gene Expression
The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. "Arbitrary unit was relative to the control gene expression (control gene = 1)".
Measured: 30 days post-treatment
Sirtuin
Sirtuin plasma levels before and 30 days post-treatment
Measured: 30 days post-treatment
Secondary outcomes (10)
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Apolipoproteins AI and B.
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- apolipoproteins AI and B
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Estradiol
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estradiol
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Platelet Aggregation.
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- platelet aggregation by ADP and norepinephrine.
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Biomarkers
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Estrone and Norepinephrine.
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estrone, norepinephrine.
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- RAGE gene expression
- "Arbitrary unit was relative to the control gene expression (control gene = 1)"
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-dynamics of clot formation: clot onset time and clot complet
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Thromboelastography.
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- slope of clot formation dynamics
Measured: 30 days post-treatment
Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-max elasticity of clot on thromboelastography
Measured: 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular System InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANTONIO DE PADUA MANSUR, InCor Heart Institute
- Investigators
- Antônio de Pádua Mansur, PHD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668836
- Sponsor's protocol ID
- 788012
- Other IDs
- 2012/01051-5
- Status last verified
- Mar 2016
- First submitted
- 14 Aug 2012
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years.
- ClinicalTrials.gov ID
- NCT01668836
- Acronym / sponsor ID
- 788012
- Keywords
- sirtuin, atherosclerosis, longevity, calorie restriction, resveratrol, vascular reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Posted 18 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women have a natural protection that gives them greater longevity. One hypothesis most commonly used is the estrogen protection in the premenopausal period. However many studies of various forms of hormone replacement therapy proved ineffective in promoting additional protection for women. Thus, it is discussed other ways of protection associated with longevity in women. Of these, the sirtuin system was found in several animal studies to be associated with longevity. This system also showed, through the involvement of several metabolic pathways, an important protection against the process of atherosclerosis. But the activity of this system in humans is unknown and if it is more active in women than in men. The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55 to 65 years, and their influence on the main metabolic pathways related to longevity and the process of atherosclerosis. The research protocol includes analysis of the influence of sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of inflammation and homeostasis, before and after the interventions with caloric restriction or resveratrol administration. It is expected of this study mechanistic conclusion for longevity and possible clinical applications in the mechanism of atherosclerosis prevention.
Detailed description
After a washout period of 15 days without medication, men and women will be randomized to the group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men) will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12 women and 12 men), a daily pill of 500mg of resveratrol. In the two moments, after the washout period and before the intervention (baseline) and after 30 days of intervention (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| men with resveratrol | Experimental | Drug: Resveratrol12 men will receive a pill with 500mg of resveratrol daily for 30 days |
| women with resveratrol | Experimental | Drug: Resveratrol12 women will receive a pill with 500mg of resveratrol daily for 30 days |
| men with caloric restriction | Active comparator | Behavioral: Caloric restriction12 men will follow a 1000 calories per day diet for 30 days |
| women with caloric restriction | Active comparator | Behavioral: Caloric restriction12 women will follow a 1000 calories per day diet for 30 days |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical history, physical examination and electrocardiogram normal
Key exclusion criteria (7 listed)
- premenopausal women (less than 1 year of natural amenorrhea)
- Body mass index ≥ 35 kg/m2
- Smoking
- Severe hypertension (diastolic blood pressure ≥ 110 mmHg)
- Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)
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 |
|---|---|---|
| Resveratrol1 pill daily containing 500 mg/d of resveratrol for 30 days | Drug | men with resveratrol, women with resveratrol |
| Caloric restrictionDiet of 1000kcal per day for 30 days | Behavioural | men with caloric restriction, women with caloric restriction |
Primary outcome
Direct Evaluation of the Sirtuin 1 Gene Expression
Time frame: 30 days post-treatment
The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. "Arbitrary unit was relative to the control gene expression (control gene = 1)".
Sirtuin
Time frame: 30 days post-treatment
Sirtuin plasma levels before and 30 days post-treatment
10 secondary outcomes
Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Apolipoproteins AI and B.
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Estradiol
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Platelet Aggregation.
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Biomarkers
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Estrone and Norepinephrine.
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Thromboelastography.
Time frame: 30 days post-treatment
Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.
Time frame: 30 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Antônio de Pádua Mansur, PHD principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol and Caloric restriction in people with Vascular System Injuries and Lipid Metabolism Disorders, run by InCor Heart Institute at 1 site in Brazil.
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 1 inclusion and 7 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 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Direct Evaluation of the Sirtuin 1 Gene Expression (time frame: 30 days post-treatment). The study lists 2 primary outcomes in all. 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 18 Apr 2016.