Assessment of the Effect of Sirtuin Activator Supplementation on Cellular, Metabolic and Anthropometric Parameters in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Concentrations of blood lipids
研究概览
简要总结
The goal of this clinical trial is to learn if the six-month supplementation with sirtuin activators can affect metabolism in 40-to-65-year old women with increased body weight. The main questions it aims to answer are:
Does sirtuin activators affect lipid and carbohydrate metabolism? Does sirtuin activators affect oxydative stress, immune functions and cell ageing?
Researchers will compare sirtuin activators to a placebo (a look-alike substance that contains no drug) to see if drug sirtuin activators works to improve metabolic status.
Participants will:
Take sirtuin activators or a placebo every day for 6 months. Visit the university once every 3 months for checkups and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age: 40-65 years
- •overweight or obese: BMI >25 kg/m2
排除标准
- •BMI < 25 kg/m2
- •sirtuin activators administration for 3 months prior to study
- •pregnancy or breastfeeding
- •recent dieting or being on calorie restricted diet
- •receiving pharmacotherapy to treat obesity, diabetes or hyperlipidemia
- •post-bariatric surgery
- •chronic kidney, liver or autoimmune diseases
- •alcohol addiction
研究组 & 干预措施
Experimental: sirtuin activators
Sirtuin activators supplementation for 6 months, daily dose of 1278 mg, taken twice a day in a capsulated form. Daily dose will contain: resveratrol - 500 mg, leucin - 467 mg, Epigallocatechin gallate - 100 mg, quercetin - 100 mg, curcuminoids - 100 mg, niacin 10.7 mg. Daily number of capsules will be 2 x 2 = 4.
干预措施: Sirtuin activators (Dietary Supplement)
Placebo comparator: placebo
Placebo will be an inactive substance (maltodextrin) provided in the same-looking capsules as sirtuin activators. Placebo will be administered twice a day, daily number of capsules will be 2 x 2 = 4.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Concentrations of blood lipids
时间窗: 6 months, two measurements: at month 0 and 6
Total cholesterol, Triacyglycerols, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesteroll
Blood glucose concentrations
时间窗: 6 months, two measurements: at month 0 and 6
Blood glucose concentration
Ageing biomarkers: transcription level of the p16INK4a gene in peripheral blood mononuclear cells
时间窗: 6 months, two measurements: at month 0 and 6
transcription level of the p16INK4a gene in peripheral blood mononuclear cells
Ageing biomarkers: telomere lenght
时间窗: 6 months, two measurements: at month 0 and 6
telomere lenght measured in DNA isolated from whole blood
Ageing biomarkers: SA beta galactosidase activity
时间窗: 6 months, two measurements: at month 0 and 6
SA beta galactosidase activity
Oxidative stress
时间窗: 6 months, two measurements: at month 0 and 6
activities of oxidative stress enzymes in blood
次要结局
- Body mass(6 months, two measurements: at month 0, 3 and 6)
- Body composition(6 months, two measurements: at month 0, 3 and 6)
- Waist and hips circumference(6 months, two measurements: at month 0, 3 and 6)
- Genotype analyisis of the Sirt1 gene(baseline)
研究者
Agata Chmurzyńska
Professor
Poznan University of Life Sciences