Ignite Creation Date:
2024-05-06 @ 12:49 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01668836
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2012-08-14
Brief Title:
Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
Sponsor:
InCor Heart Institute
Organization:
InCor Heart Institute
Study Overview
Official Title:
Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 201201051-5 | OTHER_GRANT | FAPESP - SAO PAULO RESEARCH FOUNDATION | None |