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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：tzipi strauss, MD
- 電話番号：972526664446
- メール：zipora.strauss@sheba.heath.gov.il
研究連絡先のバックアップ
- 名前：evelyne bischof, MD PhD
- 電話番号：972512504301
- メール：bischofevelyne@gmail.com
研究場所
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Tel Aviv
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Ramat Gan、Tel Aviv、イスラエル、5220001
- 募集
- Sheba medical center
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コンタクト：
- Evelyne Bischof, MD PhD
- 電話番号：00972512504301
- メール：bischofevelyne@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ：対照群
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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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実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Biomarkers of Aging optimization
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Blood-Based Biological Age at 12 Months
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Evelyne Bischof, MD PhD、Sheba medical center
- 主任研究者：Abigail Goshen, PhD、Sheba medical center
- 主任研究者：Tzipi Strauss, MD、Sheba medical center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 0761-23-SCM
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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