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

Lipid Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01668836
• Other study ID #: 788012
• Secondary ID: 2012/01051-5
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2012
• Last updated: August 17, 2012
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2012
• Source: InCor Heart Institute
• Contact: Antônio de Pádua Mansur, PHD
• Phone: 00551126615387
• Email: antonio.mansur[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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 subjetcs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Disfunction
• Lipid Metabolism Disorders
• Metabolic Diseases
• Vascular System Injuries

Intervention

Drug:
• Resveratrol
1 pill daily containing 500 mg/d of resveratrol for 30 days

Behavioral:
• Caloric restriction
Diet of 1000kcal per day for 30 days

Locations

Country	Name	City	State
Brazil	INCOR - Heart Institute	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences between men and women.	We will also compare women vs men baseline and final data.	30 days	No
Primary	Direct evaluation of the Sirtuin 1 levels	The Sirtuin 1 system will be measured through analysis of mRNA expression in periferic blood. This analysis will be done before and after the intervention with caloric restriction or resveratrol administration.	30 days	No
Secondary	Influence of the Sirtuin 1 system on biomarkers and endothelial function.	For indirect analysis of the situin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration: serum HDL, LDL, lipoprotein(a), apolipoprotein AI and B, ultra-sensitive C reative protein, non-esterified fatty acids, antioxidants, insulin, estradiol, estrone, tumor necrosis factor-alpha, interleukin-6.; RAGE (Receptor for Advanced Glycation End Product) mRNA expression; analysis of platelet aggregation; analysis of the vascular reactivity of the endothelium	30 days	No