To assess the effects of Resveratrol-Copper Supplementation on inflammatory cytokines and general wellbeing in healthy individuals aged 70-75 years: an Open Label, Single Arm study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- -Total Cholesterol
研究概览
简要总结
As we age, our bodies experience increased inflammation, reduced metabolic activity, and weakened immune systems, all of which can contribute to health issues such as heart disease, diabetes, and memory problems. The nutraceuticals resveratrol (R) and copper (Cu) are recognised for their potential health benefits; however, their combined effects in older adults remain largely unknown.
The purpose of this study is to determine whether resveratrol-copper (R-Cu) supplements can help ostensibly healthy people in the 70-75 age range by lowering inflammation, increasing metabolism, and improving general health. To find out whether this combination helps, we will be administering the R-Cu over period of 6 month and monitor the effects on key health indicators like blood sugar, cholesterol, and inflammatory cytokines. We will also monitor the effects of R-Cu on the immune system, and liver, kidneys and cognitive functions. The goal is to see if this supplement can help older adults stay healthier and prevent age-related diseases.
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
- 70.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •The individuals should be ostensibly healthy, defined by the absence of any known illnesses.
- •Volunteers who are normotensives or with well-controlled hypertension.
- •Well controlled HTN is defined as subjects having blood pressure under 140/90 on not more than three anti-hypertensive agents.
- •(Average of three recordings of blood pressure taken in sitting position 10 minutes apart will be considered).
- •Volunteers who are euglycemic or with well-controlled diabetes.
- •Well controlled diabetes is defined as HbA1c less than or equal to 6.5 percent pre-diabetic range on not more than three oral hypoglycaemic agents.
- •Volunteers with normal lipid profile defined as total cholesterol and LDL levels not more than borderline high with or without hypolipidemic drugs -Able to provide written informed consent.
- •No current use of immunosuppressive medications or treatments that influence.
- •inflammatory or immune responses in the 4 weeks preceding enrolment into the study.
排除标准
- •Presence of chronic inflammatory diseases or severe infection.
- •Severe liver or renal disease.
- •Known allergies to Resveratrol, copper.
- •Those with major psychiatric disorders.
结局指标
主要结局
-Total Cholesterol
时间窗: 6 months
The composite primary endpoint will include 10% change from baseline in at least one of the following Biochemical Markers after 6 months of Resveratrol-Copper supplementation:
时间窗: 6 months
-C-Reactive Protein
时间窗: 6 months
-Glycosylated Haemoglobin (HbA1c)
时间窗: 6 months
次要结局
- -Changes in Cytokine Profiles to assess the modulation of systemic inflammation.(-Changes in Immune Cell Frequencies to evaluate the effect of RCU on immune cell modulation.)
研究者
Dr Indraneel Mittra
Advance Centre for Treatment Research and Education in Cancer Tata Memorial Centre