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RecruitingNCT07596576SHARPUpdated May 19, 2026

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

An interventional study of healthspan personalized protocol and Control in Healthy Aging, Healthspan and Biological Age, sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • healthy longevity
  • healthspan
  • geromedicine
  • biological age
  • health trajectories
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy older adults >50 years old men and women

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1,500 participants (estimated)

Study arms

  • 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

  • Sham comparator
    control group

    Other: Control

Interventions

  • Otherhealthspan 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.

  • OtherControl

    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.

05

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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)

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Sheba Medical Center
    Ramat Gan, Tel Aviv 5220001, Israel
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07596576
Lead sponsor
Sheba Medical Center
Responsible party
Tzipi Strauss, MD MSc (PI, Sheba Medical Center) — Principal investigator
First posted
May 19, 2026
Start date
Mar 1, 2024
Primary completion
Mar 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
May 19, 2026

Study contacts

tzipi strauss, MD
Contact
zipora.strauss@sheba.heath.gov.il
972526664446
evelyne bischof, MD PhD
Contact
bischofevelyne@gmail.com
972512504301
Evelyne Bischof, MD PhD
principal investigator · Sheba Medical Center
Abigail Goshen, PhD
principal investigator · Sheba Medical Center
Tzipi Strauss, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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