Clinical trial NCT01668836: Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
Official title: Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular System Injuries
Lipid Metabolism Disorders
Endothelial Disfunction
Keywords: sirtuin
atherosclerosis
longevity
calorie restriction
resveratrol
vascular reactivity
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* clinical history, physical examination and electrocardiogram normal

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Direct Evaluation of the Sirtuin 1 Gene Expression
timeFrame: 30 days post-treatment
measure: Sirtuin
timeFrame: 30 days post-treatment
Secondary outcomes:
measure: Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Apolipoproteins AI and B.
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Estradiol
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Platelet Aggregation.
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Biomarkers
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Estrone and Norepinephrine.
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Thromboelastography.
timeFrame: 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.
timeFrame: 30 days post-treatment
Other outcomes:
measure: Differences Between Men and Women.
timeFrame: 30 days
Locations:
city: São Paulo
country: Brazil
facility: INCOR - Heart Institute
Study officials:
affiliation: InCor Heart Institute
name: Antônio de Pádua Mansur, PHD
role: PRINCIPAL_INVESTIGATOR
References: