N/A
N=48
Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
Vascular System Injuries · Lipid Metabolism Disorders · Endothelial Disfunction
Bottom Line
View on ClinicalTrials.gov: NCT01668836 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Direct Evaluation of the Sirtuin 1 Gene Expression — 11.04; 11.43; 12.84; 12.05 arbitrary unit relative to control gene
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resveratrol (Drug); Caloric restriction (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- InCor Heart Institute
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Direct Evaluation of the Sirtuin 1 Gene Expression |
11.04; 11.43; 12.84; 12.05 | — |
| PRIMARY Sirtuin |
4.84; 6.67; 6.14; 5.46 | — |
| SECONDARY Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein. |
43.00; 53.33; 41.08; 62.92; 125.50; 153.58 | — |
| SECONDARY Influence of the Sirtuin 1 System on Apolipoproteins AI and B. |
1.33; 1.55; 1.29; 1.57; 0.95; 1.13 | — |
| SECONDARY Influence of the Sirtuin 1 System on Estradiol |
38.92; 34.81; 42.13; 29.05 | — |
| SECONDARY Influence of the Sirtuin 1 System on Platelet Aggregation. |
88.03; 88.96; 87.32; 87.24; 81.06; 81.77 | — |
| SECONDARY Influence of the Sirtuin 1 System on Biomarkers |
22.45; 23.73; 8.83; 24.67; 79.00; 80.58 | — |
| SECONDARY Influence of the Sirtuin 1 System on Estrone and Norepinephrine. |
219.33; 227.83; 190.83; 329.00; 14.92; 13.23 | — |
| SECONDARY Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression |
11.88; 12.78; 12.17; 11.75 | — |
| SECONDARY Influence of the Sirtuin 1 System on Thromboelastography Clot Formation. |
38.00; 35.50; 40.42; 35.67; 100.83; 89.00 | — |
| SECONDARY Influence of the Sirtuin 1 System on Thromboelastography. |
106.83; 158.67; 115.42; 156.75 | — |
| SECONDARY Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography. |
1690.58; 2059.83; 1691.50; 2041.12 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01668836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.