Clinical Trials Directory

Trials / Completed

CompletedNCT01668836

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
InCor Heart Institute · Academic / Other
Sex
All
Age
55 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGResveratrol1 pill daily containing 500 mg/d of resveratrol for 30 days
BEHAVIORALCaloric restrictionDiet of 1000kcal per day for 30 days

Timeline

Start date
2012-08-01
Primary completion
2014-07-01
Completion
2014-12-01
First posted
2012-08-20
Last updated
2016-04-18
Results posted
2016-04-18

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01668836. Inclusion in this directory is not an endorsement.