Evaluation of the Effect of Seasonality on Biological Age in Adults

NCT07242833 | Recruiting

• 1 other identifier: 2509NR
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to provide insights on how seasonal variations influence biological age and enhance the design and analysis of long-term lifestyle interventions targeting biological clocks. Aging is a gradual decline in cellular and organ functions, significantly increasing the risk of non-communicable and infectious diseases. Recent research has focused on identifying aging biomarkers that can better predict functional capability in healthy individuals. Biological age clocks, which can be measured from samples like blood or saliva, are emerging as valuable tools for assessing the pace of aging and calculating age acceleration-the difference between chronological and biological age. These clocks utilize molecular and clinical data, including DNA methylation and plasma proteomics, to predict future health outcomes, such as disease risk and mortality. Various DNA methylation-based clocks have been developed, with the Dunedin Pace of Aging (PoAm) offering a more precise modeling of physiological changes over time. Lifestyle factors, including diet and physical activity, can influence age acceleration, suggesting that lifestyle interventions may impact biological aging. Current evidence indicates that three specific epigenetic clocks-PhenoAge, GrimAge, and Dunedin PACE-are particularly effective in detecting beneficial effects on aging trajectories. However, the stability of these clocks during long-term lifestyle interventions remains unclear, as they can exhibit variability over short periods and may be affected by factors influenced by seasonal changes, such as Vitamin D levels, climate, and white blood cells composition. To investigate these seasonal effects on biological age, a proposed observational study will track changes over a 12-month period in middle-aged and older adults.

Conditions

Aging, Healthy; BIOLOGICAL CLOCKS; Biological Clock Disturbance; Aging; Aging, Biological

Keywords

aging; biological age; biological clock; lifestyle

Outcome Measures

Primary Outcomes (1)

• Effect of seasonality (meaning change between summer and winter observed in western Europe) on biological age calculated through different clocks in adults

  Inter seasons (winter vs summer) variation in the difference between epigenetic age and chronological age, named "acceleration", calculated using the Phenoage, GrimAge and DunedinPace clock.

  From enrollment, 2 times over one year, 1 during summer and one during winter

Secondary Outcomes (3)

• Underlying factors explaining the seasonal differences in biological age measurements across various epigenetic clocks

  From enrollment, 4 timepoints, one per season, throughout the whole study duration (1 year).

• Differences and associations in biological age measurements between various epigenetic clocks.

  From enrollment, 4 timepoints, one per season, throughout the whole study duration (1 year).

• Relationship between biological age and individuals' self-assessment of their overall health.

  From enrollment, 4 timepoints, one per season, throughout the whole study duration (1 year).

Study Arms (1)

Adults (above or equal 40 y of age)

Males and females aged over 40 years, inclusive, in good health or with a stable, well-controlled chronic medical conditions with a body mass index ≥18.5 kg/m².

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study we will aim to enroll a total of 60 participants (accounting for a 20% drop out rate), living in Switzerland, that are over 40-year-old. The study aims to enroll male and female with balanced representation of each sex.

You may qualify if:

• Males and females aged over 40 years, inclusive, at enrolment.
• Assessed by the investigator to be in general good health or have stable, well-controlled chronic medical conditions (e.g. hypertension, type 2 diabetes, etc.) that are not expected to interfere with study participation or outcomes. (Note: stable medical condition is defined as controlled medical condition, with no change in medication, worsening of the condition, or hospitalization in the past 3 months prior to enrolment).
• Body mass index (BMI) ≥18.5 kg/m².
• Able to understand and to sign a written informed consent prior to study enrolment.
• Willing and able to comply with the requirements for participation in this study.

You may not qualify if:

• Any past or on-going significant medical/surgical condition and/or psychiatric condition, which in the opinion of the investigator may risk participant's wellbeing/safety, impede participant compliance with study procedures or ability to complete the study and/or could confound the primary objectives of the study (such as seasonal allergy).
• Any acute illness or any recent medical/surgical intervention, including vaccination, within 21 days prior to enrolment.
• Female participants who are pregnant or intending to become pregnant, lactating and/or breastfeeding
• Currently participating in another interventional research study.
• Family or direct hierarchical relationship with the research team members.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Lab

Lausanne, CH, 1000, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Carolina Stambolsky, MD

  Nestlé Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ambra Giorgetti, PhD

CONTACT

+41765218487; ambra.giorgetti@rd.nestle.com

Caroline Le Roy, PhD

CONTACT

+41217859479; Caroline.LeRoy@rd.nestle.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CH (1)