Evaluation of the Effect of Seasonality on Biological Age in Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of seasonality (meaning change between summer and winter observed in western Europe) on biological age calculated through different clocks in adults
研究概览
简要总结
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.
详细描述
Quality measures: the investigator will ensure protection of participant's personal data and that all reports, publications, participant samples, and any other disclosures, except where required by laws. The processing of personal and medical data will follow the Swiss regulation in matter of data privacy, and in conformity with the ORH (Human Research Ordinance) regulation, Art. 5. Participants are identified only by a participant identification number and site identification number to maintain participant confidentiality. On the CRFs and other project specific documents, participants are only identified by their unique participant number. All participant study records will be kept safely in an access-controlled area. Identification code lists linking participant names to participant identification numbers will be stored separate from participant records. The data will be coded. The participant identification list will only be accessible by the site team and identifiable information will only be kept in the investigator file. The investigator file is a secure and certified electronic system (Veeva Vault) dedicated for protecting that study information from unauthorized or accidental disclosure, from alteration, deletion, copying, and theft.
The coded data are captured into the Electronic Data Capture (EDC), Medidata RAVE ensures traceability (audit trail). The data recorded into the EDC are only accessible to the Data Manager, site personnel, and study members.
After the analyses of biological samples, the results are captured into another system named LabKey in a password-protected manner and only accessible by the laboratory technicians responsible for analyses. The final laboratory data will then be sent from LabKey to the assigned data manager via a secured SharePoint containing audit trail. RAVE and LabKey, as well as the external results are integrated into LSAF, a software dedicated to the statistical analysis, which is password controlled, and accessible only to the statistician and the Data Manager. The servers of each software and their back-up servers are hosted i.e. the United States (Medidata RAVE), Germany (LSAF), and Switzerland (LabKey). Biological material in this project is not identified by participant name but by a unique participant number. Biological material is appropriately stored in a restricted area only accessible to authorized personnel.
In case of data transfer, Société des Produits Nestlé S.A. will maintain high standards of confidentiality and protection of participant personal data. Clinical information will not be released without the written permission of the participant, except for monitoring by Regulatory Authorities or the study sponsor. The Principal Investigator or designee will implement and maintain appropriate technical and organizational measures to ensure accessibility to participants of their personal data and their results of biological analysis collected during the study. Upon request, the Principal Investigator or designee will ensure to provide extracts of personal data to participants. The Principal Investigator or designee will implement appropriate procedures to immediately inform the sponsor about any participant's request to rectify or delete their personal data or biological samples during the study. The investigational site files, including the list of codes, will be kept, and archived separately in a secure repository compliant to Nestlé policies with respect to data privacy by the research team for 25 years, even if the candidate is not included in the research project. The Trial Master file will be kept separately for 25 years as per Nestlé policy.
In addition to the current study, the participants will be proposed to consider providing consent for "further re-use" of their biological samples and data in the broader scope of Nestlé Center of Biological Resources (NCBR); if they consent to this, the samples and health related data will be handled as described in the biobank regulations (CERVD opinion - Req. 2020-00307).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Effect of seasonality (meaning change between summer and winter observed in western Europe) on biological age calculated through different clocks in adults
时间窗: From enrollment, 2 times over one year, 1 during summer and one during winter
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.
次要结局
- 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).)
- 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).)