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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: tzipi strauss, MD
- 전화번호: 972526664446
- 이메일: zipora.strauss@sheba.heath.gov.il
연구 연락처 백업
- 이름: evelyne bischof, MD PhD
- 전화번호: 972512504301
- 이메일: bischofevelyne@gmail.com
연구 장소
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Tel Aviv
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Ramat Gan, Tel Aviv, 이스라엘, 5220001
- 모병
- Sheba medical center
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연락하다:
- Evelyne Bischof, MD PhD
- 전화번호: 00972512504301
- 이메일: bischofevelyne@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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가짜 비교기: 대조군
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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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Biomarkers of Aging optimization
기간: 12 months
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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.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Blood-Based Biological Age at 12 Months
기간: 12 months
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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.
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12 months
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Change From Baseline in Telomere Length at 12 Months
기간: 12 months
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Evelyne Bischof, MD PhD, Sheba medical center
- 수석 연구원: Abigail Goshen, PhD, Sheba medical center
- 수석 연구원: Tzipi Strauss, MD, Sheba medical center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 0761-23-SCM
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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