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临床试验/NCT01668836
NCT01668836已完成不适用

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

InCor Heart Institute1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Direct Evaluation of the Sirtuin 1 Gene Expression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
55 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical history, physical examination and electrocardiogram normal

排除标准

  • premenopausal women (less than 1 year of natural amenorrhea)
  • Body mass index ≥ 35 kg/m2
  • Severe hypertension (diastolic blood pressure ≥ 110 mmHg)
  • Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)
  • 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.

研究组 & 干预措施

men with resveratrol

Experimental

12 men will receive a pill with 500mg of resveratrol daily for 30 days

干预措施: Resveratrol (Drug)

women with resveratrol

Experimental

12 women will receive a pill with 500mg of resveratrol daily for 30 days

干预措施: Resveratrol (Drug)

men with caloric restriction

Active Comparator

12 men will follow a 1000 calories per day diet for 30 days

干预措施: Caloric restriction (Behavioral)

women with caloric restriction

Active Comparator

12 women will follow a 1000 calories per day diet for 30 days

干预措施: Caloric restriction (Behavioral)

结局指标

主要结局

Direct Evaluation of the Sirtuin 1 Gene Expression

时间窗: 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)".

Sirtuin

时间窗: 30 days post-treatment

Sirtuin plasma levels before and 30 days post-treatment

次要结局

  • Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Apolipoproteins AI and B.(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Estradiol(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Platelet Aggregation.(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Biomarkers(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Estrone and Norepinephrine.(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Thromboelastography.(30 days post-treatment)
  • Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.(30 days post-treatment)

研究者

发起方
InCor Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANTONIO DE PADUA MANSUR

PHD

InCor Heart Institute

研究点 (1)

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