노인의 혈관 기능을 개선하는 피세틴
노인의 혈관 기능 개선을 위한 피세틴을 이용한 세놀리틱 치료의 임상적 번역
This is a pilot clinical trial to test the efficacy of intermittent treatment with the flavonoid compound fisetin for improving vascular endothelial function and reducing aortic stiffness in older adults. This trial will also determine the potential mechanisms by which fisetin may improve vascular function, including by decreasing mitochondrial oxidative stress, cellular senescence and senescence-associated secretory phenotype (SASP) factors in circulation. Lastly, safety, tolerability and adherence of fisetin treatment will be assessed.
연구 개요
상세 설명
Cellular senescence increases with aging and contributes to physiological dysfunction. Studies in animal models show that the flavonoid compound fisetin is an effective treatment for reducing cellular senescence and improving vascular function with aging. No published studies have used fisetin to target cellular senescence in older adults to improve vascular function. In addition, the biological reasons (mechanisms) by which fistin may improve vascular function in older adults has not been assessed. This study will evaluate if intermittent treatment with fisetin in older adults improves vascular function, reduces biological markers of cellular senescence, oxidative stress and inflammatory factors produced by senescent cells (i.e., senescence-associated secretory phenotype factors). The study will also evaluate safety, tolerability and adherence with fisetin treatment.
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Colorado
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Boulder, Colorado, 미국, 80305
- University of Colorado Boulder
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 65 years or older
- Women must be postmenopausal
- Body mass index (BMI) <40 kg/m2
- Willing to accept random assignment
- Weight stable in the prior 2 months (<2 kg weight change) and willing to remain weight stable throughout the study
- Ability to understand study procedures and to comply with them for the entire length of the study
- No blood donation within 8 weeks prior to baseline testing; willingness to abstain from blood donation during the study and for 8 weeks after study completion
- Absence of established, serious, unstable, chronic clinical disease (e.g., unstable CVD) as determined by study physician of record based on subject medical history, physical examination, resting ECG and standard clinical blood chemistries
Exclusion Criteria:
- Inability to refrain from alcohol for 24 hours prior to outcome assessment
- Individuals taking fisetin, quercetin, luteolin, Dasatinib, piperlongumine or Navitoclax (supplements or drugs with established senolytic effects) within 6 months prior to baseline testing; should new research reveal other dietary supplements or drugs with potential senolytic effects, their use will be evaluated, and their use may lead to exclusion of the subject by the PI
- New use of regular cardiovascular-acting medication which, in the opinion of the PI, affects the outcomes of the study within 3 months prior to starting baseline testing as reported during medication review during screening (these individuals could be enrolled after 3 months of regular use)
- Chronic use of a dietary supplement which, in the opinion of the PI, affects the outcomes of the study, within 1 month prior to starting baseline testing as reported during medication review during screening (these individuals could be enrolled after 1 month of regular use)
- Active malignancy (including myeloma) or malignancy that was active within 5 years prior to baseline testing
- Inability or unwillingness of individual to give written informed consent
- Current or past participation within 3 months in another clinical trial that, in the opinion of the PI, would affect the outcomes of the study
- Known hypersensitivity or allergy to fisetin
- Blood donation within 2 months prior to baseline testing
- Resting blood pressure >160 mmHg systolic or >110 mmHg diastolic
- Regular vigorous aerobic/endurance exercise
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Fisetin
Fisetin will be administered in an intermittent manner with two, three-day dosing periods at a dose of 2 mg/kg/day separated by two weeks. |
Fisetin dietary supplement |
|
위약 비교기: Placebo
Placebo capsules identical in appearance to fistin capsules will be administered in an intermittent manner with two, three-day dosing periods separated by two weeks. |
Placebo capsules identical in appearance to fisetin capsules |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in endothelial function at 1 month
기간: 1 month
|
Brachial artery flow-mediated dilation |
1 month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in aortic stiffness at 1 month
기간: 1 month
|
Carotid-femoral pulse wave velocity |
1 month
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in suppression of endothelial function by mitochondrial oxidative stress at 1 month
기간: 1 month
|
Change in brachial artery flow-mediated dilation with acute, supratherapeutic MitoQ (160mg) |
1 month
|
|
Change from baseline in endothelial cell markers of cellular senescence at 1 month
기간: 1 month
|
Endothelial cell abundance of p16 and p21 |
1 month
|
|
Change from baseline in blood cell markers of cellular senescence at 1 month
기간: 1 month
|
p16-positive T-cells |
1 month
|
|
Change from baseline in plasma markers of the senescence-associated secretory phenotype
기간: 1 month
|
Circulating pro-inflammatory cytokines and chemokines |
1 month
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Matthew J Rossman, PhD, University of Colorado, Boulder
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 23-0288
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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