Background: Population aging is accelerating rapidly in Israel and worldwide, necessitating adaptation of the healthcare system and considering new approaches that serve the needs of older adult populations.
Working hypothesis and aims: We hypothesize that a personalized health and behavior intervention program will decrease the biological age as assessed by several biological aging clocks and improve functional and cognitive performance among older adults.
Methods: We propose to conduct a randomized study among healthy community-dwelling elderly subjects (\>50 years old). The study will include an extensive aging assessment and imaging protocol (baseline assessment), including comprehensive physical, functional, sensory, cognitive, and mental assessment. Each participant in the intervention group will receive a personalized intervention program based on an integrative systems approach analysis. In addition, a uniquely developed application will track compliance and monitor physiological data through a provided wearable device. The control group will be assessed at baseline without receiving an intervention program. Each participant will visit the center aging after 6 months for a blood test and after 12 months for a second extensive diagnostic protocol, similar to the baseline assessment protocol. About 1,500 subjects will be recruited to participate in the study.
Expected results: Obtaining data at two points will allow us to examine efficiency and compliance with a personalized intervention program based on integrative systems analysis models. We expect biological age, general well-being, and various clinical and psychosocial outcomes in the intervention group will decrease and improve compared to the control group.
Study importance and relevance: The obtained results may help establish evidence-based healthy aging diagnostics protocols and an effective personalized intervention program that might be applied, with proper modifications, to national healthcare organizations for the general older adult population. In addition, to provides a scientific basis on which policymakers and intervention programs can rely to develop national guidelines for promoting extended health.
Healthy older adults >50 years old men and women
A former diagnostic of a significant cognitive reduction (MoCa score < 24 ).
Former diagnosis of neurodegenerative disease as Alzheimer's disease, Parkinson's disease, Lewy body dementia.
Former diagnosis of psychiatric disease.
In the past two years, underwent chemotherapy or radiation therapy.
Crossover
healthspan personalized protocol
Other interventionThe study will include an extensive aging assessment and imaging protocol (baseline assessment), including comprehensive physical, functional, sensory, cognitive, and mental assessment. Each participant in the intervention group will receive a personalized intervention program based on an integrative systems approach analysis. In addition, a uniquely developed application will track compliance and monitor physiological data through a provided wearable device. Each participant will visit the center aging after 6 months for a blood test and after 12 months for a second extensive diagnostic protocol, similar to the baseline assessment protocol.
Control
Other interventionThe control group will be assessed at baseline without receiving an intervention program. Each participant will visit the center aging after 6 months for a blood test and after 12 months for a second extensive diagnostic protocol, similar to the baseline assessment protocol.
Biomarkers of Aging optimization
Epigenetic biological age will be measured using DNA methylation-based aging clocks. The outcome will be reported as the change in epigenetic biological age, in years, from baseline to 12 months.
Change From Baseline in Blood-Based Biological Age at 12 Months
Blood-based biological age will be calculated from routine laboratory biomarkers using a biological age algorithm. The outcome will be reported as the change in blood-based biological age, in years, from baseline to 12 months.
Change From Baseline in Telomere Length at 12 Months
Telomere length will be measured in blood samples. The outcome will be reported as the change in telomere length from baseline to 12 months. Unit of Measure: KiloBase (KB)
Click on the lead sponsor to view all of their trials.
