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NCT Number: NCT07596576

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, Tel Aviv, 5220001, Israel

Location status: Recruiting

Location contact

Evelyne Bischof, MD PhD

CONTACT

[email protected]

00972512504301

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy older adults >50 years old men and women

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Biomarkers of Aging optimization

    Time frame: 12 months

    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.

Secondary outcomes

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

    Time frame: 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.

  2. Change From Baseline in Telomere Length at 12 Months

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

evelyne bischof, MD PhD

CONTACT

[email protected]

972512504301

tzipi strauss, MD

CONTACT

[email protected]

972526664446

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Sheba Healthspan Research Population (SHARP) Trial

Acronym: SHARP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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