Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
2 other identifiers
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
April 18, 2016
CompletedApril 18, 2016
March 1, 2016
1.9 years
August 14, 2012
August 24, 2015
March 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Direct Evaluation of the Sirtuin 1 Gene Expression
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)".
30 days post-treatment
Sirtuin
Sirtuin plasma levels before and 30 days post-treatment
30 days post-treatment
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Other Outcomes (1)
Differences Between Men and Women.
30 days
Study Arms (4)
men with resveratrol
EXPERIMENTAL12 men will receive a pill with 500mg of resveratrol daily for 30 days
women with resveratrol
EXPERIMENTAL12 women will receive a pill with 500mg of resveratrol daily for 30 days
men with caloric restriction
ACTIVE COMPARATOR12 men will follow a 1000 calories per day diet for 30 days
women with caloric restriction
ACTIVE COMPARATOR12 women will follow a 1000 calories per day diet for 30 days
Interventions
1 pill daily containing 500 mg/d of resveratrol for 30 days
Diet of 1000kcal per day for 30 days
Eligibility Criteria
You may qualify if:
- clinical history, physical examination and electrocardiogram normal
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
INCOR - Heart Institute
São Paulo, São Paulo, 05403-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Antonio de Padua Mansur - Associate Professor
- Organization
- Heart Institute (InCor), University of São Paulo Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Antônio de Pádua Mansur, PHD
InCor Heart Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 20, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
April 18, 2016
Results First Posted
April 18, 2016
Record last verified: 2016-03