Safety and Effectiveness of Resveratrol in Promoting Sirtuin 1 Activation and Enhancing Health in Elderly Adults: A Prospective Interventional Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess then effect of resveratrol on sirtuin 1 during the study period
研究概览
简要总结
Summary****IntroductionAging leads to a decline in organ function, contributing to chronic illnesses such as diabetes, Alzheimer’s, and heart disease. Cellular senescence, oxidative stress, and mitochondrial dysfunction accelerate aging. Resveratrol, a polyphenol with antioxidant and anti-inflammatory properties, activates the SIRT1 pathway, potentially improving mitochondrial function and reducing oxidative stress. This study aims to assess whether resveratrol can enhance cognitive function and physical health in elderly adults.
Methodology
- Study Design: Prospective interventional study.
- Inclusion Criteria: Elderly adults (60–75 years), stable diabetic or hypertensive patients, willing to give consent.
- Exclusion Criteria: Severe cardiac or respiratory dysfunction, high liver enzyme levels, chronic alcohol/drug abuse, cognitive impairment, or previous resveratrol use.
- Intervention: 500 mg/day of Resveratrol.
- Assessments:
- Baseline and follow-up assessments at 45 and 90 days.
- SIRT1 expression levels.
- Six-minute walk test (6MWT) for physical capacity.
- Montreal Cognitive Assessment (MoCA) for cognitive function.
- Quality of life (EuroQol-5D-5L).
- Adverse event monitoring. Need for StudyWith increasing elderly populations, research on safe anti-aging interventions is crucial. Resveratrol has shown promising results in improving mitochondrial function, reducing inflammation, and potentially mitigating age-related diseases. This study aims to provide evidence of its effectiveness in real-world clinical settings.
Procedure
- Screening & Enrollment: Participants are selected based on inclusion and exclusion criteria.
- Baseline Assessment: Demographics, SIRT1 levels, 6MWT, MoCA, and quality of life scores are recorded.
- Intervention: Daily 500 mg resveratrol supplementation with adherence monitoring.
- Follow-ups (Day 45 & 90): Reassessment of key parameters and adverse event reporting.
- Statistical Analysis: Paired t-test to compare changes in key outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Men and women of age 60-75 years.
- •If diabetic, should be on stable oral hypoglycemic medications for at least 3 months.
- •If hypertensive, on stable anti-hypertensive medications for at least 3 months.
- •Willing to give written informed consent.
排除标准
- •Severe respiratory or cardiac dysfunction.
- •Abnormally elevated liver enzymes ALT and or AST more than tree times ULN.
- •eGFR less than thirty ml per min Elevated creatinine phosphokinase CPK more than three times ULN.
- •Chronic alcoholic or drug abuse subjects.
- •Known cases of malignancy and HIV infection.
- •Use of antioxidant supplements.
- •Use of Hormone replacement therapy.
- •History of significant head injury or any major surgery.
- •Previous use of resveratrol in the past three months.
- •Severe cognitive impairment or dementia.
- •Subject who participated in any other clinical investigation using an experimental drug in the past three months.
- •Participants who are not willing to attend treatment schedule regularly.
结局指标
主要结局
To assess then effect of resveratrol on sirtuin 1 during the study period
时间窗: Measurement of sirtuin 1 on day 0, day 45 and day 90
Gradual recovery from symptoms
时间窗: Measurement of sirtuin 1 on day 0, day 45 and day 90
次要结局
- To find out the MoCa score improvement(Six-minute Walk test (6MWT))
研究者
Dr K Subramaniyan
SRM hospital and research centre,SRM IST
