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| Name | Class |
|---|---|
| Xprize Foundation | UNKNOWN |
| Abinopharm, Inc | NETWORK |
| DoNotAge.org | INDUSTRY |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Fundamental intervention | Experimental | Participants receive a multimodal lifestyle intervention including sleep optimization, dietary counseling, supervised exercise with an exergaming component, motivational interviewing, and baseline nutritional supplementation. |
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| 2 Augmented intervention | Experimental | Participants receive the fundamental intervention and additional personalized supplements based on baseline muscle mass, cardiorespiratory fitness, and cognitive performance, with possible mid-study adjustment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep and dietary counseling | Other | Sleep hygiene education and individualized dietary recommendations delivered throughout the intervention period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cardiorespiratory fitness (VO₂peak) | VO₂peak will be determined using standardized cardiopulmonary exercise testing on an electronically braked cycle ergometer | Baseline, Week 4, and Week 8 |
| Change from baseline in muscle strength (one-repetition maximum (1RM)) | Change from baseline in muscle strength assessed by one-repetition maximum (1RM) testing | Baseline, Week 4, and Week 8 |
| Change from baseline in muscle mass (Ultrasound imaging) | Muscle thickness of the thigh will be assessed non-invasively using B-mode ultrasound with a linear array transducer. | Baseline, Week 4, and Week 8 |
| Change from baseline in cognitive performance (NIH Toolbox Fluid Cognition Composite) | Change from baseline in cognitive performance assessed by the NIH Toolbox Fluid Cognition Composite score. | Baseline, Week 4, and Week 8 |
| Change from baseline in immune function (CD4+: CD8+ ratio) | Change from baseline in immune status assessed by the CD4+:CD8+ T-cell ratio. | Baseline, Week 4, and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Circulating Cytokines, Chemokines, and Growth Factors | 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) | Baseline, Week 4, and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Study participation and retention rates | 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. | 8 weeks |
| Adherence to sleep intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajla Hodzic Kuerec, MD, PhD | Contact | +65 91686091 | ahkuerec@nus.edu.sg | |
| Mazzarine Dotou, PhD | Contact | +65 87264704 | mazzarine@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Andrea Britta Maier, MD, PhD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD11 Clinical Research Centre, #03-01, 10 Medical Drive, Singapore 117597 | Recruiting | Singapore | Singapore | 117597 | Singapore |
De-identified individual participant data (IPD) underlying the primary, secondary and other outcome measures reported in this study, will be made available on request. Data will be fully de-identified and will not include direct identifiers. Raw multi-omics data (e.g., DNA methylation, proteomics, lipidomics, microbiome sequencing) may be shared in processed or aggregated form, as appropriate, to minimize re-identification risk.
IPD and supporting information will become available after study completion and publication of the main findings, with the end date to be determined.
Access to de-identified IPD will be provided upon reasonable request to qualified researchers with a methodologically sound proposal and appropriate ethical approval. Requests will be reviewed by the study investigators and data will be shared under a data use agreement specifying permitted uses, data security requirements, and restrictions on re-identification.
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This is an open-label, single arm interventional feasibility study in which 20 participants (aged 50 to 80 years) will receive an 8-week multimodal precision geromedicine intervention.
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| Supervised exercise and exergaming program | Other | Supervised dual-task cognitive-physical training with an exergaming component conducted three times per week, 60 minutes per session. |
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| Motivational interviewing | Behavioral | Structured motivational interviewing sessions aimed at improving adherence to lifestyle and supplementation interventions conducted two times throughout the study. |
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| Whey protein | Dietary Supplement | 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 |
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| Creatine Monohydrate | Dietary Supplement | 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 |
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| Fucoidan | Dietary Supplement | Daily fucoidan supplementation (SIRT6Activator®, DoNotAge.org) at a dose of 2.4 g/day. |
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| Urolithin A | Dietary Supplement | Participants below the 50th percentile for normative muscle mass receive urolithin A (StanYouth™ Urolithin A, Bonerge) at 250 mg/day. |
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| Nicotinamide Mononucleotide (NMN) | Dietary Supplement | Participants below the 50th percentile for normative VO₂peak receive NMN (AbinoNutra® NMN, Abinopharm, Inc.) at 300 mg/day. |
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| Multivitamin | Dietary Supplement | Participants below the 50th percentile for normative cognitive performance receive a gender-specific multivitamin (Centrum), 1 tablet daily. |
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| Ergothioneine | Dietary Supplement | 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. |
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| Change from baseline in advanced glycation end-products | Change from baseline in tissue advanced glycation end-products (AGEs), assessed using skin autofluorescence. | Baseline, Week 4, and Week 8 |
| Change from baseline in methylation levels | 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. | Baseline, Week 4, and Week 8 |
| Change from baseline in blood multi-omics profiles | Blood-based multi-omics profiles, including proteomics and lipidomics, will be assessed using standard analytical platforms. | Baseline, Week 4, and Week 8 |
| Change from baseline in gut microbiome composition and fuctional capacity | 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. | Baseline and Week 8 |
| Change from Baseline in Body Composition (Fat and Lean Mass) | Body composition, including fat mass and lean mass, will be assessed using bioelectrical impedance analysis. | Baseline, Week 4, and Week 8 |
| Change from Baseline in Arterial Stiffness (Carotid-Femoral Pulse Wave Velocity) | Carotid-femoral pulse wave velocity (cf-PWV) will be measured using applanation tonometry at the carotid artery combined with a thigh cuff. | Baseline, Week 4, and Week 8 |
| Change from baseline in sleep quality | 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. | Baseline, Week 4, and Week 8 |
| Change from baseline in skin color and elasticity | Skin color and elasticity will be assessed using a standardized colorimeter | Baseline, Week 4, and Week 8 |
| Change from baseline in oral health indicators | 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. | Baseline, Week 4, and Week 8 |
| Change from baseline in reproductive health | 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. | Baseline, Week 4, and Week 8 |
| Change from Baseline in Waist and Hip Circumferences | Waist and hip circumferences will be measured using a standardized measuring tape. | Baseline, Week 4, and Week 8 |
| Change from Baseline in Blood Pressure (Systolic and Diastolic) | Brachial systolic and diastolic blood pressures will be measured using an automated cuff. | Baseline, Week 4, and Week 8 |
| Change from baseline in Physical activity levels | 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. | Baseline, Week 4, and Week 8 |
| Change from Baseline in Quality of Life | Quality of life will be assessed using the 36-Item Short Form Survey (SF-36) and EuroQol-5D-5L (EQ-5D). | Baseline, Week 4, and Week 8 |
| Change from baseline in Psychological Well-being | 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). | Baseline, Week 4, and Week 8 |
| Change from baseline in wellness | Overall wellness will be assessed using a validated wellness questionnaire. | Baseline, Week 4, and Week 8 |
| Change from baseline in food intake | Participants will record dietary intake using a 3-day food diary. Changes from baseline in nutrient and energy intake will be analyzed. | Baseline, Week 4, and Week 8 |
| Change from Baseline in Grip Strength | Grip strength will be measured using a hand-held dynamometer (Jamar Plus+). | Baseline, Week 4, and Week 8 |
| Change from Baseline in Standard Clinical Blood Biomarkers | 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. | Baseline, Week 4, and Week 8 |
Adherence to the sleep intervention expressed as the number and percentage of nights with ≥7 hours of sleep, recorded using a wearable device. |
| 8 weeks |
| Adherence to fundamental supplementation | 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. | 8 weeks |
| Adherence to augmented supplementation | 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. | 8 weeks |
| Adherence to exercise and exergaming intervention | Adherence to the exercise intervention expressed as the number and percentage of aerobic training, strength training, and exergaming sessions attended, recorded by study staff. | 8 weeks |
| ID | Term |
|---|---|
| D012890 | Sleep |
| D015596 | Nutrition Assessment |
| D062405 | Motivational Interviewing |
| D000067816 | Whey Proteins |
| D003401 | Creatine |
| C007789 | fucoidan |
| C026423 | 3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one |
| D009537 | Nicotinamide Mononucleotide |
| C067316 | Geritol |
| D004880 | Ergothioneine |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D012265 | Ribonucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D006639 | Histidine |
| D000598 | Amino Acids, Cyclic |
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