- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02909699
Cardiovascular Health of Older Adults and Resveratrol (CORE) (CORE)
Cardiovascular Health of Older Adults and Resveratrol
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Florida
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Gainesville, Florida, 미국, 32610
- University of Florida
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
All the criteria are the same as in the parent R01 (IRB201400439). Participants must meet all inclusion criteria listed below in order to participate in this study.
- Ability to understand study procedures and to comply with them for the entire length of the study;
- Age 65 years and older;
- Moderately functioning (i.e. a summary score of 4 - 12 on the Short Physical Performance Battery);
- Body Mass Index (BMI) range: 20-39.9 kg/m2;
- Willingness to undergo all testing procedures.
Exclusion Criteria:
All candidates meeting any of the exclusion criteria listed below at baseline will be disqualified from study participation.
- Non-English speaking individual.
- Failure to provide informed consent;
- Allergy/sensitivity to grapes or Japanese knotweed;
- Current dietary supplementation of grape seed extract or ginko biloba;
- Consumption of ≥ 8 oz. of red wine/dealcoholized red wine/red or purple grape juice more than once weekly;
- Consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum in the previous 90 days;
- Active treatment for cancer, stroke (< 6 months), peripheral vascular disease, coronary artery disease, myocardial infarction (< 6 months), congestive heart failure (stage III or IV), valvular heart disease, major psychiatric disease, severe anemia (blood levels of Hemoglobin < 8 g/dl), bleeding disorders or other blood disorders, liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity ( < 6 months), upper or lower extremity amputation, or Parkinson's disease;
- Cognitive impairment (i.e. Mini Mental Status Exam ≤ 23 & Clinical Dementia Rating ≥1);
- History of significant head injury;
- Physical activity (i.e. running, bicycling, etc.) ≥ 150 min/week;
- Excessive alcohol use (> 2 drinks/day) or alcohol abuse (> 5 drinks/day for males, or > 4 drinks/day for females);
- History of substance abuse within the past six months;
- Mood disorder (i.e. Center for Epidemiological Studies - Depression (CES-D) ≥ 16);
- History of tobacco use within the past three years;
- Resting heart rate > 120 bpm at screening visit;
- Systolic blood pressure > 160 mm Hg at screening visit;
- Diastolic blood pressure > 90 mm Hg at screening visit;
- Fasting glucose ≥ 126 mg/dL at screening visit;
- Abnormalities in blood chemistry parameters, defined by blood chemistry marker outside of healthy range) as determined by study physician
Current use of
- anabolic treatments (e.g. growth hormone or testosterone),
- anticholinesterase inhibitor (e.g. Aricept),
- hormone replacement (e.g. Estrogen),
- anticoagulant therapies (note: aspirin -anti-platelet use (≤ 81mg/day) is permitted) or
- use of anti-inflammatory medications more than 3 times per week.;
- Participation in another non-observational clinical trial, or has received an investigational product within 30 days prior to screening/enrollment;
- Refuse to refrain from CoQ10 or alpha-lipoic acid while enrolled in the study.
Temporary Exclusion Criteria
A person meeting any of the following temporary exclusion criteria at the time of screening would not be enrolled but may be re-screened at a later date. A period of 4 weeks is the minimum amount of time required before re-screening for the following conditions can be done.
- Recent bacterial/viral infection (< 2 weeks);
- Acute febrile illness in past 2 months;
- High blood pressure (i.e. ≥ 140/90 mm Hg but ≤ 160/90) at the screening visit; Major surgery or hip/knee replacement (< 6 months);
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Dose 1
1,000mg of resveratrol per day (1 pill 3 times per day).
This ancillary study will be observational without drug administration.
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In this trial, cardiovascular function will be measured without drug administration.
The drug will be administered within the main trial.
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Dose 2
1,500mg of resveratrol per day (1 pill 3 times per day)
|
In this trial, cardiovascular function will be measured without drug administration.
The drug will be administered within the main trial.
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Placebo
Alike looking 1 pill 3 times per day
|
In this trial, cardiovascular function will be measured without drug administration.
The drug will be administered within the main trial.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Speckle tracking analyses
기간: Change from Baseline and 3 months
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Speckle tracking analyses will be performed using advanced quantification software version.
Short axis and long axis images will be automatically divided into six segments.
Automated tracking of myocardial speckles will be reviewed and manually adjusted as minimally as possible.
The tracking quality of each segment will be visually evaluated and if tracking is felt to be inaccurate, strain analysis of that segment will not be included.
Speckle tracking analysis provides peak and time to peak measures of circumferential, radial and longitudinal strain and strain rate in 18 left ventricle (LV) segments.
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Change from Baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Flow-mediated dilation
기간: Change from baseline and 3 months
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A duplex ultrasound image of the brachial artery (i.e., 2-D image and spectral Doppler waveforms) will be obtained ∼7 cm proximal to the antecubital fossa.
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Change from baseline and 3 months
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Autophagy measured by Enzyme-linked immunosorbent assay (ELISA)
기간: Baseline and 3 months
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Autophagy will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.
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Baseline and 3 months
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Endothelin-1 protein expression will be measured by Western Blot
기간: Change from baseline and 3 months
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Endothelin-1 protein expression will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.
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Change from baseline and 3 months
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Endothelial function endothelial nitric oxide synthase (eNOS) will be measured by Western Blot
기간: Change from baseline and 3 months
|
Endothelial function endothelial nitric oxide synthase will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.
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Change from baseline and 3 months
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Endothelin-1 protein expression will be measured by Enzyme-linked immunosorbent assay (ELISA)
기간: Change from baseline and 3 months
|
Endothelin-1 protein expression will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.
|
Change from baseline and 3 months
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Endothelial function endothelial nitric oxide synthase (eNOS) will be measured by Enzyme-linked immunosorbent assay (ELISA)
기간: Change from baseline and 3 months
|
Endothelial function endothelial nitric oxide synthase will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.
|
Change from baseline and 3 months
|
Autophagy measured by Western Blot
기간: Change from Baseline and 3 months
|
Autophagy will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.
|
Change from Baseline and 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert T Mankowski, Ph.D., University of Florida
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- IRB201601756
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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