PRecision gerOMedicinE: Tailored Healthy agEing With Lifestyle, sUpplements and drugS (PROMETHEUS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in cardiorespiratory fitness (VO₂peak)
研究概览
简要总结
As the population ages, the growing prevalence of age-related diseases is creating substantial challenges for healthcare systems worldwide. Current therapeutic strategies often target individual diseases and decrease mortality without improving healthspan. The geroscience hypothesis suggests that targeting the ageing process itself could prevent, delay, or manage the severity of multiple age-related diseases concurrently, thereby improving overall healthspan and reducing healthcare burdens.
Emerging research highlights several interconnected hallmarks of aging, such as mitochondrial dysfunction, chronic inflammation, impaired autophagy, and immune dysregulation, as modifiable through targeted interventions. Precision geromedicine represents a paradigm shift in addressing these processes, combining baseline diagnostics with individualized treatment strategies that adapt over time based on patient response. This approach integrates lifestyle modifications, dietary supplements, and pharmacological agents to optimize physical, cognitive, and immune function across the lifespan .
详细描述
This study aims to evaluate the effectiveness and feasibility of a personalized, multimodal precision geromedicine intervention targeting key hallmarks of aging. We hypothesize that an 8-week intervention combining lifestyle modification and targeted supplementation will improve biological and clinical markers of aging in middle-aged to older (50-80 years) adults.
Participants within this age range are chosen because they are more likely to encounter early declines in muscle, immune, and cognitive functions, while still being responsive to preventive measures. The criteria for inclusion concentrate on individuals scoring below the 75th percentile for normative values in VO₂peak and cognitive performance. This demographic presents an optimal opportunity for interventions aimed at prolonging healthspan and postponing functional decline.
Hypothesis
The multimodal precision geromedicine intervention will be feasible to conduct and effective in improving muscle, cognitive, and immune function, as well as other biological, clinical, and digital biomarkers of aging in middle aged to older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50-80 years (both male and female)
- •Relatively healthy and in stable health condition
- •Not engaged in regular resistance or aerobic training in the past 12 months (i.e., untrained)
- •VO₂peak below the 75th percentile for age- and sex-specific norms
- •Cognitive performance below 75th percentile on the NIH Toolbox Cognitive Function Battery
- •Willing and able to comply with exercise and supplementation protocols
- •English-literate (can read and understand English)
- •Provides written informed consent
- •Deemed to have mental capacity, as assessed by the Principal Investigator
- •Are able to attend all research visits for screening and research data collection at MD11, Yong Loo Lin School of Medicine, National University of Singapore
排除标准
- •Significant change in medication in the past 3 months
- •History of major cardiovascular disease (e.g., coronary artery disease, heart failure, stroke)
- •More than two unstable chronic conditions (e.g., hypertension, diabetes, osteoarthritis, COPD)
- •Known allergies to soy, shellfish/seaweed, mushrooms, or supplement ingredients
- •Participation in another interventional clinical trial
- •Current use of any study-related supplement unless willing to stop
- •Any medical, psychiatric, or cognitive condition deemed by the PI to jeopardise safety or compliance
- •Pregnant or planning pregnancy during the study period
- •Any conditions deemed by PI that jeopardize the safety or study compliance
研究组 & 干预措施
1 Fundamental intervention
Participants receive a multimodal lifestyle intervention including sleep optimization, dietary counseling, supervised exercise with an exergaming component, motivational interviewing, and baseline nutritional supplementation.
干预措施: Sleep and dietary counseling (Other)
1 Fundamental intervention
Participants receive a multimodal lifestyle intervention including sleep optimization, dietary counseling, supervised exercise with an exergaming component, motivational interviewing, and baseline nutritional supplementation.
干预措施: Supervised exercise and exergaming program (Other)
1 Fundamental intervention
Participants receive a multimodal lifestyle intervention including sleep optimization, dietary counseling, supervised exercise with an exergaming component, motivational interviewing, and baseline nutritional supplementation.
干预措施: Motivational interviewing (Behavioral)
1 Fundamental intervention
Participants receive a multimodal lifestyle intervention including sleep optimization, dietary counseling, supervised exercise with an exergaming component, motivational interviewing, and baseline nutritional supplementation.
干预措施: Whey protein (Dietary Supplement)
1 Fundamental intervention
Participants receive a multimodal lifestyle intervention including sleep optimization, dietary counseling, supervised exercise with an exergaming component, motivational interviewing, and baseline nutritional supplementation.
干预措施: Creatine Monohydrate (Dietary Supplement)
1 Fundamental intervention
Participants receive a multimodal lifestyle intervention including sleep optimization, dietary counseling, supervised exercise with an exergaming component, motivational interviewing, and baseline nutritional supplementation.
干预措施: Fucoidan (Dietary Supplement)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Fucoidan (Dietary Supplement)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Sleep and dietary counseling (Other)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Supervised exercise and exergaming program (Other)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Motivational interviewing (Behavioral)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Whey protein (Dietary Supplement)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Creatine Monohydrate (Dietary Supplement)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Urolithin A (Dietary Supplement)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Nicotinamide Mononucleotide (NMN) (Dietary Supplement)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Multivitamin (Dietary Supplement)
2 Augmented intervention
Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment.
干预措施: Ergothioneine (Dietary Supplement)
结局指标
主要结局
Change from baseline in cardiorespiratory fitness (VO₂peak)
时间窗: Baseline, Week 4, and Week 8
VO₂peak will be determined using standardized cardiopulmonary exercise testing on an electronically braked cycle ergometer
Change from baseline in muscle strength (one-repetition maximum (1RM))
时间窗: Baseline, Week 4, and Week 8
Change from baseline in muscle strength assessed by one-repetition maximum (1RM) testing
Change from baseline in muscle mass (Ultrasound imaging)
时间窗: Baseline, Week 4, and Week 8
Muscle thickness of the thigh will be assessed non-invasively using B-mode ultrasound with a linear array transducer.
Change from baseline in cognitive performance (NIH Toolbox Fluid Cognition Composite)
时间窗: Baseline, Week 4, and Week 8
Change from baseline in cognitive performance assessed by the NIH Toolbox Fluid Cognition Composite score.
Change from baseline in immune function (CD4+: CD8+ ratio)
时间窗: Baseline, Week 4, and Week 8
Change from baseline in immune status assessed by the CD4+:CD8+ T-cell ratio.
次要结局
- Change from Baseline in Blood Pressure (Systolic and Diastolic)(Baseline, Week 4, and Week 8)
- Change from Baseline in Circulating Cytokines, Chemokines, and Growth Factors(Baseline, Week 4, and Week 8)
- Change from baseline in advanced glycation end-products(Baseline, Week 4, and Week 8)
- Change from baseline in methylation levels(Baseline, Week 4, and Week 8)
- Change from baseline in blood multi-omics profiles(Baseline, Week 4, and Week 8)
- Change from baseline in gut microbiome composition and fuctional capacity(Baseline and Week 8)
- Change from Baseline in Body Composition (Fat and Lean Mass)(Baseline, Week 4, and Week 8)
- Change from Baseline in Arterial Stiffness (Carotid-Femoral Pulse Wave Velocity)(Baseline, Week 4, and Week 8)
- Change from baseline in sleep quality(Baseline, Week 4, and Week 8)
- Change from baseline in skin color and elasticity(Baseline, Week 4, and Week 8)
- Change from baseline in oral health indicators(Baseline, Week 4, and Week 8)
- Change from baseline in reproductive health(Baseline, Week 4, and Week 8)
- Change from Baseline in Waist and Hip Circumferences(Baseline, Week 4, and Week 8)
- Change from baseline in Physical activity levels(Baseline, Week 4, and Week 8)
- Change from Baseline in Quality of Life(Baseline, Week 4, and Week 8)
- Change from baseline in Psychological Well-being(Baseline, Week 4, and Week 8)
- Change from baseline in wellness(Baseline, Week 4, and Week 8)
- Change from baseline in food intake(Baseline, Week 4, and Week 8)
- Change from Baseline in Grip Strength(Baseline, Week 4, and Week 8)
- Change from Baseline in Standard Clinical Blood Biomarkers(Baseline, Week 4, and Week 8)
研究者
Andrea Maier
Oon Chiew Seng Professor in Medicine, Healthy Ageing and Dementia Research
National University of Singapore