NCT Number: NCT07451496
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 .
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Singapore, 117597
Location status: Recruiting
Ajla Hodzic Kuerec, MD, PhD
CONTACT
Andrea Britta Maier, MD, PHD, FRACP
PRINCIPAL_INVESTIGATOR
Mazzarine Dotou, PhD, MBA
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sleep hygiene education and individualized dietary recommendations delivered throughout the intervention period.
Supervised dual-task cognitive-physical training with an exergaming component conducted three times per week, 60 minutes per session.
Structured motivational interviewing sessions aimed at improving adherence to lifestyle and supplementation interventions conducted two times throughout the study.
Daily whey protein supplementation (GOLD STANDARD 100% ISOLATE, Optimum Nutrition) provided using a standard 30 g scoop (~25 g protein). Dosage based on body weight:
40-59 kg: 1 scoop/day
60-89 kg: 1.5 scoops/day
≥90 kg: 2 scoops/day
Daily creatine supplementation (Micronized Creatine Monohydrate, Optimum Nutrition; 1.25 g per capsule). Dosage based on body weight:
40-59 kg: 4 capsules/day
60-89 kg: 6 capsules/day
≥90 kg: 8 capsules/day
Daily fucoidan supplementation (SIRT6Activator®, DoNotAge.org) at a dose of 2.4 g/day.
Participants below the 50th percentile for normative muscle mass receive urolithin A (StanYouth™ Urolithin A, Bonerge) at 250 mg/day.
Participants below the 50th percentile for normative VO₂peak receive NMN (AbinoNutra® NMN, Abinopharm, Inc.) at 300 mg/day.
Participants below the 50th percentile for normative cognitive performance receive a gender-specific multivitamin (Centrum), 1 tablet daily.
At the midpoint of the intervention (1 month), participants may receive ergothioneine (Dr.Ergo® L-ergothioneine) at 25 mg three times per week based on individual response.
Time frame: Baseline, Week 4, and Week 8
VO₂peak will be determined using standardized cardiopulmonary exercise testing on an electronically braked cycle ergometer
Time frame: Baseline, Week 4, and Week 8
Change from baseline in muscle strength assessed by one-repetition maximum (1RM) testing
Time frame: 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.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in cognitive performance assessed by the NIH Toolbox Fluid Cognition Composite score.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in immune status assessed by the CD4+:CD8+ T-cell ratio.
Time frame: Baseline, Week 4, and Week 8
Change from baseline in circulating cytokines, chemokines, and growth factors. These will be quantified in plasma using enzyme-linked immunosorbent assays (ELISA) or multiplex immunoassays based on xMAP technology. Concentrations will be expressed in standard units (e.g., pg/mL)
Time frame: Baseline, Week 4, and Week 8
Change from baseline in tissue advanced glycation end-products (AGEs), assessed using skin autofluorescence.
Time frame: Baseline, Week 4, and Week 8
Genome-wide DNA methylation levels will be measured using Illumina BeadChips, which will be scanned on the iScan System. Methylation levels will be quantitatively determined from the fluorescence signals.
Time frame: Baseline, Week 4, and Week 8
Blood-based multi-omics profiles, including proteomics and lipidomics, will be assessed using standard analytical platforms.
Time frame: Baseline and Week 8
Gut microbiome composition and functional capacity will be characterized using short-read shotgun metagenomic sequencing of DNA extracted from stool samples. Changes from baseline to Week 8 will be assessed at the species and functional gene levels.
Time frame: Baseline, Week 4, and Week 8
Body composition, including fat mass and lean mass, will be assessed using bioelectrical impedance analysis.
Time frame: Baseline, Week 4, and Week 8
Carotid-femoral pulse wave velocity (cf-PWV) will be measured using applanation tonometry at the carotid artery combined with a thigh cuff.
Time frame: Baseline, Week 4, and Week 8
Sleep quality will be assessed using validated questionnaires, including the Pittsburgh Sleep Quality Index (PSQI) and the SATED questionnaire, as well as objective sleep metrics collected via the Oura Ring wearable device. Changes from baseline to each follow-up time point will be reported.
Time frame: Baseline, Week 4, and Week 8
Skin color and elasticity will be assessed using a standardized colorimeter
Time frame: Baseline, Week 4, and Week 8
Oral health status and mucosal condition will be assessed using validated questionnaires, including the Geriatric Oral Health Assessment Index (GOHAI) and the Modified CDC/AAP oral health questionnaires.
Time frame: Baseline, Week 4, and Week 8
Reproductive health will be assessed using validated questionnaires. For men, the Androgen Deficiency in Aging Males (ADAM) and Brief Sexual Function Inventory (BSFI) will be used; for women, the Female Sexual Function Index (FSFI) will be used.
Time frame: Baseline, Week 4, and Week 8
Waist and hip circumferences will be measured using a standardized measuring tape.
Time frame: Baseline, Week 4, and Week 8
Brachial systolic and diastolic blood pressures will be measured using an automated cuff.
Time frame: Baseline, Week 4, and Week 8
Physical activity will be objectively measured using the Oura Ring wearable device, which passively tracks daily steps, activity intensity, and sleep duration throughout the intervention period.
Time frame: Baseline, Week 4, and Week 8
Quality of life will be assessed using the 36-Item Short Form Survey (SF-36) and EuroQol-5D-5L (EQ-5D).
Time frame: Baseline, Week 4, and Week 8
Exhaustion will be evaluated using two items from the Center for Epidemiologic Studies Depression Scale (CES-D). Depression, anxiety, and stress levels will be measured using the 21-item Depression Anxiety and Stress Scale (DASS-21).
Time frame: Baseline, Week 4, and Week 8
Overall wellness will be assessed using a validated wellness questionnaire.
Time frame: Baseline, Week 4, and Week 8
Participants will record dietary intake using a 3-day food diary. Changes from baseline in nutrient and energy intake will be analyzed.
Time frame: Baseline, Week 4, and Week 8
Grip strength will be measured using a hand-held dynamometer (Jamar Plus+).
Time frame: Baseline, Week 4, and Week 8
Standard clinical blood tests, including hematology, liver and renal function profiles, lipid profile, glucose, HbA1c, insulin, and high-sensitivity C-reactive protein (hs-CRP), will be conducted by an accredited clinical laboratory.
Time frame: 8 weeks
Participation rate defined as the percentage of eligible participants enrolled, and dropout rate defined as the percentage of participants who discontinue the study and reasons for dropout.
Time frame: 8 weeks
Adherence to the sleep intervention expressed as the number and percentage of nights with ≥7 hours of sleep, recorded using a wearable device.
Time frame: 8 weeks
Adherence to whey protein, creatine, and fucoidan supplementation assessed as the number and percentage of prescribed doses taken, verified by counting and weighing returned supplement bottles.
Time frame: 8 weeks
Adherence to urolithin A, NMN, multivitamin, ergothioneine, or additional fucoidan assessed as the number and percentage of prescribed doses taken, verified by counting and weighing returned supplement bottles.
Time frame: 8 weeks
Adherence to the exercise intervention expressed as the number and percentage of aerobic training, strength training, and exergaming sessions attended, recorded by study staff.
Contact information is provided by the study sponsor or research team.
Ajla Hodzic Kuerec, MD, PhD
CONTACT
Mazzarine Dotou, PhD
CONTACT
National University of Singapore
Other
Acronym: PROMETHEUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07672834
Ageing
London, United Kingdom
View Trial DetailsNCT07419633
Ageing, Ageing and Geriatric Health
Montreal, Quebec, Canada
View Trial DetailsNCT06599021
Ageing, Deglutition Disorders
Gothenburg, Sweden
View Trial DetailsNCT06676839
Ageing
Castres, France
View Trial Details