Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years

University of São Paulo (USP)

Status: Completed

Conditions: Vascular System Injuries; Lipid Metabolism Disorders; Endothelial Disfunction

Treatments: Behavioral: Caloric restriction; Drug: Resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01668836

2012/01051-5 (Other Grant/Funding Number)

788012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 55 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

men with resveratrol

Experimental group

Description:

12 men will receive a pill with 500mg of resveratrol daily for 30 days

Treatment:

Drug: Resveratrol

women with resveratrol

Experimental group

Description:

12 women will receive a pill with 500mg of resveratrol daily for 30 days

Treatment:

Drug: Resveratrol

men with caloric restriction

Active Comparator group

Description:

12 men will follow a 1000 calories per day diet for 30 days

Treatment:

Behavioral: Caloric restriction

women with caloric restriction

Active Comparator group

Description:

12 women will follow a 1000 calories per day diet for 30 days

Treatment:

Behavioral: Caloric restriction