NCT07574359 RUSS-AGE: Creating of a Biological Age Calculator and Study of Aging Phenotypes in the Russian Population
| NCT ID | NCT07574359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pirogov Russian National Research Medical University |
| Condition | Healthy Aging |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,500 participants |
| Start Date | 2023-01-12 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,500 participants in total. It began in 2023-01-12 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-center, cross-sectional, observational study aimed at developing biological age calculators specifically for the Russian population investigating various aging phenotypes. Aging is a complex process that varies greatly between individuals, meaning that chronological age does not always reflect one's biological health status. The primary goal of this study is to identify and analyze a comprehensive set of markers (including socioeconomic factors, lifestyle, physical parameters, cognitive function, and laboratory biomarkers) that best reflect the aging process. Using this data, researchers will create a mathematical model to estimate a person's "biological age." The study plans to enroll at least 3,500 male and female volunteers aged 18 years and older from across Russia. Participants will be divided into 5-year age groups (e.g., 18-24, 25-29, up to 90+ years) to ensure broad representation. Participation involves a single visit to a clinical center. During this visit, participants will undergo: Interview and questionnaires (assessing health history, lifestyle, socioeconomic status, diet, sleep, and quality of life). Physical examination and anthropometric measurements (height, weight, blood pressure, grip strength). Functional and cognitive tests (e.g., walking speed, balance tests, memory and attention tasks tailored to age). Collection of biomaterials: blood (50 ml), urine, and stool samples for extensive laboratory analysis, including routine tests and specialized aging biomarkers. Part of the biomaterials will be biobanked for future scientific research. Instrumental examinations for a subset of participants: Depending on the center's capabilities and the study protocol, some participants may also undergo additional assessments such as densitometry (bone density scan), bioimpedance analysis (body composition), and brain MRI. The results are expected to lead to the creation of a validated biological age calculator for the Russian population. This tool could help identify targets for interventions to promote healthy aging and, in the future, potentially predict the risk of developing age-related chronic diseases.
Eligibility Criteria
Inclusion Criteria: Signing the informed consent form to participate in the study. Participant's age was 18 years or older at the time of inclusion in the study. \- Exclusion Criteria: 1. Refusal to participate in the study or to provide informed consent. 2. History or medical records indicating the presence of infectious diseases (Hepatitis C, Hepatitis B, including HBsAg carrier status, HIV infection). 3. Presence of an acute illness/condition, exacerbation of a chronic disease, or surgical intervention within the last month prior to study inclusion. 4. Lack of remission from an oncological disease or ongoing anti-tumor therapy initiated less than three years prior to study inclusion. 5. Severe cognitive or sensory impairments and mental disorders that, in the investigator's opinion, preclude adequate communication with the subject. 6. Severe forms of chronic non-communicable diseases: life-threatening cardiac arrhythmias, chronic heart failure NYHA Class III-IV, left ventricular ejection fraction \<40%, ischemic heart disease CCS Class III-IV, chronic kidney disease Stages 4-5, type 1 diabetes mellitus, type 2 diabetes mellitus with terminal stages of complications, systemic connective tissue diseases, chronic obstructive pulmonary disease with respiratory failure of Grade 1 or higher, bronchial asthma requiring glucocorticosteroid therapy, osteoarthritis Kellgren-Lawrence Grade IV, body mass index (BMI) ≥40 kg/m², as well as documented history of myocardial infarction (MI) or acute cerebrovascular accident (stroke). 7. Pregnancy or lactation (breastfeeding). 8. Any other factors that, in the investigator's opinion, may preclude the participant's inclusion in the study. Additional exclusion criteria for participants undergoing stool sample collection: 9. Use of systemic antibiotics for 3 or more days within the 3 months prior to the study start. 10. Any invasive procedures on the large intestine within the last 3 weeks prior to the study start.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07574359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07574359 currently recruiting?
Yes, NCT07574359 is actively recruiting participants. Contact the research team at machehina_lv@rgnkc.ru for enrollment information.
Where is the NCT07574359 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07574359 clinical trial?
NCT07574359 is sponsored by Pirogov Russian National Research Medical University. The trial plans to enroll 3,500 participants.