An observational study in Healthy Aging and Biomarkers, sponsored by Pirogov Russian National Research Medical University. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Pirogov Russian National Research Medical University · Observational
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.
Background and Rationale Chronological age is an imprecise measure of an individual's functional health and aging trajectory. Biological age, an integrative measure of systemic physiological state, is a more accurate predictor of age-related morbidity and mortality. While multiple biomarkers and models for estimating biological age exist, they are primarily derived from non-Russian populations and may not account for region-specific genetic, lifestyle, and environmental factors. The RUSS AGE study aims to address this gap by establishing a comprehensive, population-specific biological age calculator for the Russian population.
Primary Objectives To develop and validate a mathematical model (calculator) for estimating biological age in the Russian adult population based on a multidimensional panel of biomarkers, clinical parameters, and functional assessments.
Secondary Objectives
Study Design This is a multi-center, cross-sectional, observational study. The study involves several visits per participant, with no interventional procedures. Data and biospecimen are collected to create a reference database and develop the predictive model. Some participants will be re-enrolled in the study with repeated data collection
Methodology Overview
Data collection is structured into comprehensive domains to capture the multifactorial nature of aging:
Physical Exam \& Anthropometry: Height, weight, BMI, waist/hip circumference, blood pressure, resting heart rate.
Functional Independence: For participants aged 65+, the Barthel Index of basic activities of daily living is assessed.
*Cognitive \& Psychological Assessment:
Emotional State: Assessed using the Hospital Anxiety and Depression Scale (HADS). Sleep quality is evaluated with the Insomnia Severity Index (ISI).
Data Analysis \& Modeling:
Statistical analysis will involve descriptive statistics and inter-group comparisons across age strata. The core analytical task will employ advanced machine learning and statistical modeling techniques (e.g., deep learning approaches, regression models) to integrate the multidimensional data (clinical, functional, cognitive, laboratory) and derive a composite index of biological age. The model's development and validation will adhere to standard practices for predictive analytics.
Governance:
The study is coordinated by the Russian Gerontological Research and Clinical Center (RGNKC), a division of the Pirogov Russian National Research Medical University. All procedures will be conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice guidelines, and relevant Russian regulatory requirements, following approval by the appropriate Independent Ethics Committee.
Pirogov Russian National Research Medical University is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria: Signing the form to participate in the study.
Participant's age was 18 years or older at the time of inclusion in the study.
-
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A representative Russian adult cohort aged 18+ both men and women
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.
Time frame: Primary Outcome - through study completion, an average of 1 year
Characterization of Aging Phenotypes
Descriptive profiles (phenotypes) of aging across 5-year age strata (from 18 to 90+ years), based on the distribution and correlation of collected variables. This includes patterns in physical function, cognitive scores, biomarker levels, and comorbidity burden.
Time frame: Secondary Outcome - through study completion, an average of 1 year
Establishment of a Biobank Repository
The number and type of biospecimens (whole blood, serum, plasma, stool, urine) successfully collected, processed, and stored for long-term preservation, enabling future research on aging mechanisms.
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
Started Jan 2023 (actual). Primary completion is estimated for Sep 2029, 80 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pirogov Russian National Research Medical University