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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by InCor Heart Institute
Sponsor:
Information provided by (Responsible Party):
ANTONIO DE PADUA MANSUR, InCor Heart Institute
ClinicalTrials.gov Identifier:
NCT01668836
First received: August 14, 2012
Last updated: August 17, 2012
Last verified: August 2012
  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.

Resource links provided by NLM:


Further study details as provided by InCor Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668836

Contacts
Contact: Antônio de Pádua Mansur, PHD 00551126615387 antonio.mansur@incor.usp.br

Locations
Brazil
INCOR - Heart Institute Recruiting
São Paulo, Brazil, 05403-900
Principal Investigator: Antônio de Pádua Mansur, PHD         
Sponsors and Collaborators
InCor Heart Institute
Investigators
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:
Resveratrol
Lipid Metabolism Disorders
Metabolic Diseases
Sphingolipidoses
Vascular System Injuries
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Cardiovascular Diseases
Central Nervous System Diseases
Genetic Diseases, Inborn
Lipid Metabolism, Inborn Errors
Lipidoses
Lysosomal Storage Diseases
Lysosomal Storage Diseases, Nervous System
Metabolism, Inborn Errors
Nervous System Diseases
Vascular Diseases
Wounds and Injuries
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014