Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vascular System Injuries Lipid Metabolism Disorders Endothelial Disfunction |
Drug: Resveratrol Behavioral: Caloric restriction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years. |
- Direct evaluation of the Sirtuin 1 levels [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Influence of the Sirtuin 1 system on biomarkers and endothelial function. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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
- Differences between men and women. [ Time Frame: 30 days ] [ Designated as safety issue: No ]We will also compare women vs men baseline and final data.
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: men with resveratrol
12 men will receive a pill with 500mg of resveratrol daily for 30 days
|
Drug: Resveratrol
1 pill daily containing 500 mg/d of resveratrol for 30 days
Other Name: resveratrol
|
|
Experimental: women with resveratrol
12 women will receive a pill with 500mg of resveratrol daily for 30 days
|
Drug: Resveratrol
1 pill daily containing 500 mg/d of resveratrol for 30 days
Other Name: resveratrol
|
|
Active Comparator: men with caloric restriction
12 men will follow a 1000kcal/day diet for 30 days
|
Behavioral: Caloric restriction
Diet of 1000kcal per day for 30 days
|
|
Active Comparator: women with caloric resctriction
12 women will follow a 1000kcal/day diet for 30 days
|
Behavioral: Caloric restriction
Diet of 1000kcal per day for 30 days
|
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 subjetcs.
Eligibility| Ages Eligible for Study: | 55 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Antônio de Pádua Mansur, PHD | 00551126615387 | antonio.mansur@incor.usp.br |
| Brazil | |
| INCOR - Heart Institute | Recruiting |
| São Paulo, Brazil, 05403-900 | |
| Principal Investigator: Antônio de Pádua Mansur, PHD | |
| Principal Investigator: | Antônio de Pádua Mansur, PHD | InCor Heart Institute |
More Information
No publications provided
| Responsible Party: | ANTONIO DE PADUA MANSUR, PHD, InCor Heart Institute |
| ClinicalTrials.gov Identifier: | NCT01668836 History of Changes |
| Other Study ID Numbers: | 788012, 2012/01051-5 |
| Study First Received: | August 14, 2012 |
| Last Updated: | August 17, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by InCor Heart Institute:
|
sirtuin atherosclerosis longevity |
calorie restriction resveratrol vascular reactivity |
Additional relevant MeSH terms:
|
Metabolic Diseases Lipid Metabolism Disorders Vascular System Injuries Vascular Diseases Cardiovascular Diseases Wounds and Injuries Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Antimutagenic Agents Anticarcinogenic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013