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| ID | Type | Description | Link |
|---|---|---|---|
| 2012/01051-5 | Other Grant/Funding Number | FAPESP - SAO PAULO RESEARCH FOUNDATION |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| men with resveratrol | Experimental | 12 men will receive a pill with 500mg of resveratrol daily for 30 days |
|
| women with resveratrol | Experimental | 12 women will receive a pill with 500mg of resveratrol daily for 30 days |
|
| men with caloric restriction | Active Comparator | 12 men will follow a 1000 calories per day diet for 30 days |
|
| women with caloric restriction | Active Comparator | 12 women will follow a 1000 calories per day diet for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | 1 pill daily containing 500 mg/d of resveratrol for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)". | 30 days post-treatment |
| Sirtuin | Sirtuin plasma levels before and 30 days post-treatment | 30 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Differences Between Men and Women. | We will also compare women vs men baseline and final data. | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antônio de Pádua Mansur, PHD | InCor Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INCOR - Heart Institute | São Paulo | São Paulo | 05403-900 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Men With Resveratrol | 12 men will receive a pill with 500mg of resveratrol daily for 30 days Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days |
| FG001 | Women With Resveratrol | 12 women will receive a pill with 500mg of resveratrol daily for 30 days Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days |
| FG002 | Men With Caloric Restriction | 12 men will follow a 1000kcal/day diet for 30 days Caloric restriction: Diet of 1000kcal per day for 30 days |
| FG003 | Women With Caloric Restriction | 12 women will follow a 1000kcal/day diet for 30 days Caloric restriction: Diet of 1000kcal per day for 30 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Men With Resveratrol | 12 men will receive a pill with 500mg of resveratrol daily for 30 days Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days |
| BG001 | Women With Resveratrol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)". | Posted | Mean | Standard Deviation | arbitrary unit relative to control gene | 30 days post-treatment |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Men With Resveratrol | 12 men will receive a pill with 500mg of resveratrol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio de Padua Mansur - Associate Professor | Heart Institute (InCor), University of São Paulo Medical School | 55-11-26615387 | apmansur@usp.br; apmansur@yahoo.com |
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| ID | Term |
|---|---|
| D057772 | Vascular System Injuries |
| D052439 | Lipid Metabolism Disorders |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014947 | Wounds and Injuries |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Caloric restriction | Behavioral | Diet of 1000kcal per day for 30 days |
|
| 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 | 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 | 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. | 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. | 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. | 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:
| 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 | 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 | 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 | 30 days post-treatment |
12 women will receive a pill with 500mg of resveratrol daily for 30 days
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days
| BG002 | Men With Caloric Restriction | 12 men will follow a 1000kcal/day diet for 30 days Caloric restriction: Diet of 1,000kcal per day for 30 days |
| BG003 | Women With Caloric Restriction | 12 women will follow a 1000kcal/day diet for 30 days Caloric restriction: Diet of 1,000kcal per day for 30 days |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | Kg/m^2 |
|
| abdominal circumference | Mean | Standard Deviation | cm |
|
| heart rate | Mean | Standard Deviation | beats/minute |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| total cholesterol | Mean | Standard Deviation | mg/dL |
|
| HDL-cholesterol | Mean | Standard Deviation | mg/dL |
|
| LDL-cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
| C-reactive protein | Mean | Standard Deviation | mg/dL |
|
| Apolipoprotein A1 | Mean | Standard Deviation | g/L |
|
| Apolipoprotein B | Mean | Standard Deviation | g/L |
|
| lipoprotein (a) | Mean | Standard Deviation | mg/dL |
|
| glucose | Mean | Standard Deviation | mg/dL |
|
| luteinizing hormone | Mean | Standard Deviation | microUI/mL |
|
| follicle stimulating hormone | Mean | Standard Deviation | microUI/mL |
|
| Estradiol | Mean | Standard Deviation | pg/mL |
|
| norepinephrine | Mean | Standard Deviation | pg/mL |
|
| Insulin | Mean | Standard Deviation | microUI/L |
|
| Sirtuin | Mean | Standard Deviation | ng/mL |
|
| Estrone | Mean | Standard Deviation | pg/mL |
|
| Sirtuin-1 gene expression by real time polimerase chain reaction "RT-PCR" | Values obtained from delta CT (cycle threshold) using as normalizer GAPDH gene. | Mean | Standard Deviation | arbitrary unit |
|
| RAGE (receptor for advanced glycation end-products) gene expression "RT-PCR" | Mean | Standard Deviation | arbitrary unit |
|
| Platelet aggregation by adenosine diphosphate (ADP) | percentage of maximum amplitude aggregation by adenosine diphosphate | Mean | Standard Deviation | % |
|
| Platelet aggregation by epinephrine | percentage of maximum amplitude aggregation | Mean | Standard Deviation | % |
|
| Nonesterified fatty acid | Mean | Standard Deviation | mmol/L |
|
| Clot onset time | Mean | Standard Deviation | seconds |
|
| Clot complete | Mean | Standard Deviation | seconds |
|
| Slope | Slope reflects activity of fibrinogen and platelet function. Denotes the speed at which solid clot was formed. Its value is reduced in presence of low levels of fibrinogen and platelet function. It shows the strength which the clot is formed. | Mean | Standard Deviation | Pascal/min |
|
| Max Elasticity | Mean | Standard Deviation | Pascal |
|
| OG002 | Men With Caloric Restriction | 12 men will follow a 1000kcal/day diet for 30 days Caloric restriction: Diet of 1000kcal per day for 30 days |
| OG003 | Women With Caloric Restriction | 12 women will follow a 1000kcal/day diet for 30 days Caloric restriction: Diet of 1000kcal per day for 30 days |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | "mg/dL" | 30 days post-treatment |
|
|
|
| Other Pre-specified | Differences Between Men and Women. | We will also compare women vs men baseline and final data. | Not Posted | 30 days |
| Primary | Sirtuin | Sirtuin plasma levels before and 30 days post-treatment | Posted | Mean | Standard Deviation | ng/mL | 30 days post-treatment |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | "g/dL" | 30 days post-treatment |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | "pg/mL" | 30 days post-treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage platelet aggregation | 30 days post-treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | "microUI/mL" | 30 days post-treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | "pg/dL" | 30 days post-treatment |
|
|
|
| Secondary | 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:
| Posted | Mean | Standard Deviation | arbitrary unit relative to control gene | 30 days post-treatment |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | "sec" | 30 days post-treatment |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | "Pascal/min" | 30 days post-treatment |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | "Pascal" | 30 days post-treatment |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Women With Resveratrol | 12 women will receive a pill with 500mg of resveratrol | 0 | 12 | 0 | 12 |
| EG002 | Men With Caloric Restriction | 12 men will follow a 1000Kcal/day of caloric restriction | 0 | 12 | 0 | 12 |
| EG003 | Women With Caloric Restriction | 12 women will follow a 1000Kcal/day of caloric restriction | 0 | 12 | 0 | 12 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| LDL-cholesterol "mg/dL" |
|
| Lipoprotein(a)"mg/dL" |
|
| total cholesterol "mg/dL" |
|
| Triglycerides "mg/dL" |
|
| C-reactive protein "mg/dL" |
|
| glucose "mg/dL" |
|
| Apolipoprotein B "g/dL" |
|
| Platelet aggregation by norepinephrine "%" |
|
| Insulin "microUI/mL" |
|
| Luteinizing hormone "microUI/mL" |
|
| Follicle stimulating hormone "microUI/mL" |
|
| Estrone"pg/dL" |
|
| Clot complet "sec" |
|