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

Sheba Healthspan Research Population (SHARP) Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Aging; Biological Age; Intrinsic Capacity; Healthspan; Immunaging
• Intervention / Treatment: Other: healthspan personalized protocol; Other: Control

Detailed Description

The SHARP study is a prospective, 12-month randomized control study on older adults to study the effect of a personalized health and behavioral intervention plan on the biomarkers of aging. Primary outcomes will be measured at baseline, 6, and 12 months (end of study). Secondary outcomes will be measured at baseline and 12 months (end of study). Participants will be randomly assigned to the intervention or control group.

The study participants will visit the Sheba longevity center between three to four times, depending on the assigned trial group (figure 1): baseline evaluation (visit 1), medical summary and intervention plan (according to the study group, visit 2), after six months for a blood sample (visit 3), and a follow-up evaluation after 12 months (visit 4).

The examination visits (visit 1 and visit 4) will include metabolic analysis through blood and sample tests for lipid, immune, hormonal, and vitamin levels, as well as microbiome and proteomics analysis. Physical and imaging assessments will involve bone density, body composition, sensory tests, grip strength, electroencephalogram (EEG), spirometry, Ankle-brachial index (ABI), and various measurements. Women will undergo gynecological exams, and menopause symptoms will be evaluated. Mental and cognitive aspects will cover well-being, depression, anxiety, and cognitive tests, while lifestyle will encompass socio-demographics, medical history, physical activity, diet, and general health status.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: tzipi strauss, MD; Phone Number: 972526664446; Email: zipora.strauss@sheba.heath.gov.il
• Study Contact Backup: Name: evelyne bischof, MD PhD; Phone Number: 972512504301; Email: bischofevelyne@gmail.com

Study Locations

• Israel
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5220001
      • Recruiting
      • Sheba Medical Center
      • Contact: Evelyne Bischof, MD PhD; Phone Number: 00972512504301; Email: bischofevelyne@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy older adults >50 years old men and women

Exclusion Criteria:

1. A former diagnostic of a significant cognitive reduction (MoCa score < 24 ).
2. Former diagnosis of neurodegenerative disease as Alzheimer's disease, Parkinson's disease, Lewy body dementia.
3. Former diagnosis of psychiatric disease.
4. In the past two years, underwent chemotherapy or radiation therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group	Other: Control; 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.
Experimental: intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	12 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Evelyne Bischof, MD PhD, Sheba Medical Center; Principal Investigator: Abigail Goshen, PhD, Sheba Medical Center; Principal Investigator: Tzipi Strauss, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: biological age; healthspan; healthy longevity; geromedicine; health trajectories
• Other Study ID Numbers: 0761-23-SCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified individual participant data will not be made publicly available at this stage due to institutional privacy regulations, ethical approvals, and participant consent limitations. Aggregate results will be reported in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No