Investigating the Effects of Monarda Didyma Extract Supplementation on Biological Aging of Susceptible Population: a Randomized, Placebo Controlled, Double Blind Parallel Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Age acceleration (AgeAcc)
研究概览
简要总结
This research aims to explore the potential benefits of supplementation of a natural ingredient, the Monarda didyma extract, to reduce / delay the biological aging of a susceptible population, thus contributing to two relevant topics in science with important social and economic implications: anti-aging strategies for wellness and healthy aging and environmental sustainability using natural products.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
- •Age: 45 - 65
排除标准
- •Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular disease (e.g., stroke, heart attack))
- •Chronic intake of medication/dietary supplements with impact on stress levels (psychologically and physiological)
- •Consumption of any dietary/nutritional supplements or functional foods
- •High caffeine intake > 5 coffee cups / day
- •Gastrointestinal diseases/conditions (ulcerative colitis, Crohn's disease, peptic ulcers, celiac disease)
- •Drug-, alcohol- and medication abuses
- •Known HIV-infection
- •Known acute or chronic hepatitis B and C infection
- •Known allergies against the mint family (labiate), especially lemon balm (la cedrella, la melissa, la citronella)
- •Pregnancy, breastfeeding or intention to become pregnant during the study
- •Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
- •Blood donation within 4 weeks prior to study start (screening) or during the study
- •Anticipating any planned changes in lifestyle for the duration of the study
- •Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
结局指标
主要结局
Age acceleration (AgeAcc)
时间窗: 12 weeks
Age acceleration as difference between DNA methylation age and chronological age (years)
DNA methylation age (DNAmAge)
时间窗: 12 weeks
DNA methylation age (years)
Leukocyte telomere length (LTL)
时间窗: 12 weeks
Leukocyte telomere length as ratio (T/S) of number telomere repeat sequences (T) to single-copy gene (S)
Mitochondrial DNA copy number (mtDNAcn)
时间窗: 12 weeks
Mitochondrial DNA copy number (mtDNAcn) as ratio (MT/S) of mitochondrial DNA copy number (MT) and the singular copy number of a gene (S)
次要结局
- Tracking of sleep using Miband 6 watch(12 weeks)
- hemoglobin(12 weeks)
- erythrocytes(12 weeks)
- Blood pressure(12 weeks)
- Salivary cortisol(12 weeks)
- Telomerase expression (∆∆Ct)(12 weeks)
- Leukocytes(12 weeks)
- MCH mean corpuscular hemoglobin(12 weeks)
- platelets(12 weeks)
- C reactive protein(12 weeks)
- interleukin 6(12 weeks)
- Questionnaire about Quality of Life: World Health Organization's Quality of Life Assessment BREF version (WHOQOL-BREF)(12 weeks)
- Tracking of mobility using Miband 6 watch(12 weeks)
- HOMA(12 weeks)
- SGPT(12 weeks)
- LDL/HDL(12 weeks)
- MCV mean corpuscular volume(12 weeks)
- HDL(12 weeks)
- AST(12 weeks)
- hematocrit(12 weeks)
- MCHC mean corpuscular hemoglobin concentration(12 weeks)
- Weight(12 weeks)
- Questionnaire about sleeping patterns: Pittsburgh Sleep Quality Index (PSQI)(12 weeks)
- Tracking of Hearth Rate using Miband 6 watch(12 weeks)
- Triglycerides(12 weeks)
- Glycemia(12 weeks)
- Insulin(12 weeks)
- Total cholesterol/HDL(12 weeks)
- Total cholesterol(12 weeks)
- LDL(12 weeks)
- GGT(12 weeks)
- Creatinine(12 weeks)
- Waist(12 weeks)
研究者
Sofia Pavanello
Full professor
University of Padova