RUSS-AGE: Creating of a Biological Age Calculator and Study of Aging Phenotypes in the Russian Population

NCT07574359 | Recruiting

• 1 other identifier: BA06/2022.1
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging; Biomarkers

Keywords

biological age; aging biomarkers; aging clock; biological age calculator; phenotypic age; aging phenotype; healthy aging; machine learning in aging

Outcome Measures

Primary Outcomes (1)

• Aging clock

  A composite, unitless numerical score derived from a mathematical model (e.g., via machine learning) that integrates multidimensional data (socioeconomic, clinical, functional, cognitive, and laboratory biomarkers). This score is the output of the developed calculator and represents the estimated biological age of an individual. The score is calculated based on data collected during the single study visit. Its validation as a predictor will be analyzed cross-sectionally against chronological age and health status.

  Primary Outcome - through study completion, an average of 1 year

Secondary Outcomes (2)

• Characterization of Aging Phenotypes

  Secondary Outcome - through study completion, an average of 1 year

• Establishment of a Biobank Repository

  Through study completion, an average of 1 year

Study Arms (1)

A representative Russian adult cohort

A representative Russian adult cohort aged 18+ both men and women

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study cohort comprises a nationally representative sample of the general Russian adult population. We plan to enroll at least 3,500 volunteers (targeting a 1:1 male-to-female ratio) aged 18 years and older. Participants will be systematically recruited across multiple clinical centers in Russia to ensure geographic and social diversity. A key feature of the design is stratified enrollment by 5-year age groups (from 18 to 90+ years), with a target of 200-300 participants per stratum.

You may not qualify if:

• Refusal to participate in the study or to provide informed consent.
• History or medical records indicating the presence of infectious diseases (Hepatitis C, Hepatitis B, including HBsAg carrier status, HIV infection).
• Severe cognitive or sensory impairments and mental disorders that, in the investigator's opinion, preclude adequate communication with the subject.
• 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).
• Pregnancy or lactation (breastfeeding).
• Use of systemic antibiotics for 3 or more days within the 3 months prior to the study start.
• Any invasive procedures on the large intestine within the last 3 weeks prior to the study start.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, 129226, Russia

RECRUITING

Related Publications (1)

• Melnitskaia A.A., Matchekhina L.V., Tkacheva O.N., Ilyushchenko A.K., Tyazhelnikov A.A., Polunin V.S., Yumukyan A.V., Strazhesko I.D. RUSS-AGE: developed research protocol for the creation of Russian biological age calculators. Russian Journal of Geriatric Medicine. 2023;16(4):239-247. doi:10.37586/2686-8636-4-2023-239-247 (In Russ.)

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool and urine samples

Central Study Contacts

Liubov Machekhina, MD, PhD

CONTACT

+79037488543; machehina_lv@rgnkc.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: May 7, 2026
• Study Start: January 12, 2023
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 7, 2026

Record last verified: 2025-10

Locations

RU (1)