Sheba Healthspan Research Population (SHARP) Trial - Sheba Longevity Center Diagnostic and Intervention Protocol to Lower Biological Age in Older Adults

NCT07596576 | Recruiting DMC

• 1 other identifier: 0761-23-SCM
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging; Intrinsic Capacity; Immunaging; Healthspan; Biological Age

Keywords

healthy longevity; healthspan; geromedicine; biological age; health trajectories

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Change From Baseline in Blood-Based Biological Age at 12 Months

  12 months

• Change From Baseline in Telomere Length at 12 Months

  12 months

Study Arms (2)

intervention group

EXPERIMENTAL

a comprehensive assessment result report, which is divided into major areas of health: cardiovascular, lifestyle habits, mental health, cognitive function, sensory health, sleep patterns, metabolic health, physical strength (stamina), women's and men's health, and biological aging; a personalized recommendation program will be tailored to the participant's assessment results.

Other: healthspan personalized protocol

control group

SHAM COMPARATOR

Other: Control

Interventions

healthspan personalized protocol OTHER

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. 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.

intervention group

Control OTHER

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.

control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy older adults \>50 years old men and women

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Tel Aviv, 5220001, Israel

RECRUITING

Study Officials

• Evelyne Bischof, MD PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Abigail Goshen, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Tzipi Strauss, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

tzipi strauss, MD

CONTACT

972526664446; zipora.strauss@sheba.heath.gov.il

evelyne bischof, MD PhD

CONTACT

972512504301; bischofevelyne@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: May 19, 2026
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

IL (1)