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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Resveratrol on Sirtuins and Apoptosis Biomarkers

NCT05808387

Coronary Artery Disease Menopause Endothelial Dysfunction

RECRUITING NA

Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease

NCT03943459

Coronary Artery Disease Progression

UNKNOWN PHASE3

Autonomic and Cardiovascular Recovery After the Acute Use of Resveratrol in Overweight and Obesity Individuals

NCT06020313

Polyphenols Cardiovascular Diseases Autonomic Nervous System

UNKNOWN NA

Nitrate, Exercise and Vascular Function in Midlife Women

NCT06527248

Healthy Menopause Hypertension +1 more

NOT_YET_RECRUITING NA

The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow and Cognitive Function

NCT05810974

Post Menopausal

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular System Injuries Lipid Metabolism Disorders Endothelial Disfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

men with resveratrol

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

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

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

women with resveratrol

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

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

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

men with caloric restriction

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

Group Type ACTIVE_COMPARATOR

Caloric restriction

Intervention Type BEHAVIORAL

Diet of 1000kcal per day for 30 days

women with caloric restriction

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

Group Type ACTIVE_COMPARATOR

Caloric restriction

Intervention Type BEHAVIORAL

Diet of 1000kcal per day for 30 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resveratrol

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

Intervention Type DRUG

Caloric restriction

Diet of 1000kcal per day for 30 days

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes