PRecision gerOMedicinE: Tailored Healthy agEing With Lifestyle, sUpplements and drugS (PROMETHEUS)

Short name PROMETHEUS

NCTNCT07451496Other idNUS-IRB-2025-393

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Not applicable
Enrollment: 20 participants (estimated)
Sponsor: National University of Singapore · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
Singapore
Start: 29 Sept 2025
Primary completion: 23 Feb 2026
Completion: 30 Jun 2026 (estimated)
First posted: 5 Mar 2026
Last update posted: 5 Mar 2026
Conditions: Ageing

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

N/A
PROMETHEUS
NCT07451496
29 Sept 2025 to est. 30 Jun 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 .

Interventions

Sleep and dietary counselingOther
Supervised exercise and exergaming programOther
Motivational interviewingBehavioral
Whey proteinDietary supplement
Creatine MonohydrateDietary supplement
FucoidanDietary supplement
Urolithin ADietary supplement
Nicotinamide Mononucleotide (NMN)Dietary supplement
MultivitaminDietary supplement
ErgothioneineDietary supplement

Arms2

Experimental
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.
Experimental
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.

Primary outcomes5

Outcomes the sponsor listed as primary.

Change from baseline in cardiorespiratory fitness (VO₂peak)
Time frame · Baseline, Week 4, and Week 8
Registry description
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))
Time frame · Baseline, Week 4, and Week 8
Registry description
Change from baseline in muscle strength assessed by one-repetition maximum (1RM) testing
Change from baseline in muscle mass (Ultrasound imaging)
Time frame · Baseline, Week 4, and Week 8
Registry description
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)
Time frame · Baseline, Week 4, and Week 8
Registry description
Change from baseline in cognitive performance assessed by the NIH Toolbox Fluid Cognition Composite score.
Change from baseline in immune function (CD4+: CD8+ ratio)
Time frame · Baseline, Week 4, and Week 8
Registry description
Change from baseline in immune status assessed by the CD4+:CD8+ T-cell ratio.

Secondary outcomes(20)

Change from Baseline in Circulating Cytokines, Chemokines, and Growth Factors
Time frame · Baseline, Week 4, and Week 8
Registry description
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)
Change from baseline in advanced glycation end-products
Time frame · Baseline, Week 4, and Week 8
Registry description
Change from baseline in tissue advanced glycation end-products (AGEs), assessed using skin autofluorescence.
Change from baseline in methylation levels
Time frame · Baseline, Week 4, and Week 8
Registry description
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.
Change from baseline in blood multi-omics profiles
Time frame · Baseline, Week 4, and Week 8
Registry description
Blood-based multi-omics profiles, including proteomics and lipidomics, will be assessed using standard analytical platforms.
Change from baseline in gut microbiome composition and fuctional capacity
Time frame · Baseline and Week 8
Registry description
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.
Change from Baseline in Body Composition (Fat and Lean Mass)
Time frame · Baseline, Week 4, and Week 8
Registry description
Body composition, including fat mass and lean mass, will be assessed using bioelectrical impedance analysis.
Change from Baseline in Arterial Stiffness (Carotid-Femoral Pulse Wave Velocity)
Time frame · Baseline, Week 4, and Week 8
Registry description
Carotid-femoral pulse wave velocity (cf-PWV) will be measured using applanation tonometry at the carotid artery combined with a thigh cuff.
Change from baseline in sleep quality
Time frame · Baseline, Week 4, and Week 8
Registry description
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.
Change from baseline in skin color and elasticity
Time frame · Baseline, Week 4, and Week 8
Registry description
Skin color and elasticity will be assessed using a standardized colorimeter
Change from baseline in oral health indicators
Time frame · Baseline, Week 4, and Week 8
Registry description
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.
Change from baseline in reproductive health
Time frame · Baseline, Week 4, and Week 8
Registry description
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.
Change from Baseline in Waist and Hip Circumferences
Time frame · Baseline, Week 4, and Week 8
Registry description
Waist and hip circumferences will be measured using a standardized measuring tape.
Change from Baseline in Blood Pressure (Systolic and Diastolic)
Time frame · Baseline, Week 4, and Week 8
Registry description
Brachial systolic and diastolic blood pressures will be measured using an automated cuff.
Change from baseline in Physical activity levels
Time frame · Baseline, Week 4, and Week 8
Registry description
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.
Change from Baseline in Quality of Life
Time frame · Baseline, Week 4, and Week 8
Registry description
Quality of life will be assessed using the 36-Item Short Form Survey (SF-36) and EuroQol-5D-5L (EQ-5D).
Change from baseline in Psychological Well-being
Time frame · Baseline, Week 4, and Week 8
Registry description
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).
Change from baseline in wellness
Time frame · Baseline, Week 4, and Week 8
Registry description
Overall wellness will be assessed using a validated wellness questionnaire.
Change from baseline in food intake
Time frame · Baseline, Week 4, and Week 8
Registry description
Participants will record dietary intake using a 3-day food diary. Changes from baseline in nutrient and energy intake will be analyzed.
Change from Baseline in Grip Strength
Time frame · Baseline, Week 4, and Week 8
Registry description
Grip strength will be measured using a hand-held dynamometer (Jamar Plus+).
Change from Baseline in Standard Clinical Blood Biomarkers
Time frame · Baseline, Week 4, and Week 8
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 50 Years up to 80 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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