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NCT Number: NCT01668836

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

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.

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Key information

Conditions

Vascular System Injuries Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Endothelial Disfunction Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases Wounds and Injuries

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INCOR - Heart Institute

São Paulo, 05403-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Drug

1 pill daily containing 500 mg/d of resveratrol for 30 days

Caloric restriction

Behavioral

Diet of 1000kcal per day for 30 days

Primary outcomes

  1. Direct Evaluation of the Sirtuin 1 Gene Expression

    Time frame: 30 days post-treatment

    The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. "Arbitrary unit was relative to the control gene expression (control gene = 1)".

  2. Sirtuin

    Time frame: 30 days post-treatment

    Sirtuin plasma levels before and 30 days post-treatment

Secondary outcomes

  1. Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.

  2. Influence of the Sirtuin 1 System on Apolipoproteins AI and B.

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • apolipoproteins AI and B

  3. Influence of the Sirtuin 1 System on Estradiol

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • estradiol

  4. Influence of the Sirtuin 1 System on Platelet Aggregation.

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • platelet aggregation by ADP and norepinephrine.

  5. Influence of the Sirtuin 1 System on Biomarkers

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.

  6. Influence of the Sirtuin 1 System on Estrone and Norepinephrine.

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • estrone, norepinephrine.

  7. Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • RAGE gene expression
    • "Arbitrary unit was relative to the control gene expression (control gene = 1)"

  8. Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    -dynamics of clot formation: clot onset time and clot complet

  9. Influence of the Sirtuin 1 System on Thromboelastography.

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    • slope of clot formation dynamics

  10. Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.

    Time frame: 30 days post-treatment

    For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:

    -max elasticity of clot on thromboelastography

Other outcomes

  1. Differences Between Men and Women.

    Time frame: 30 days

    We will also compare women vs men baseline and final data.

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2012
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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