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

18 mei 2026 bijgewerkt door: Tzipi Strauss, MD MSc, Sheba Medical Center

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1500

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Israël
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israël, 5220001
        • Werving
        • Sheba medical center
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: controlegroep
Ander: 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.
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Biomarkers of Aging optimization
Tijdsspanne: 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.
12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Blood-Based Biological Age at 12 Months
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sheba Medical Center

Onderzoekers

  • Hoofdonderzoeker: Evelyne Bischof, MD PhD, Sheba medical center
  • Hoofdonderzoeker: Abigail Goshen, PhD, Sheba medical center
  • Hoofdonderzoeker: Tzipi Strauss, MD, Sheba medical center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2024

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

16 september 2025

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

18 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 0761-23-SCM

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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