Cardiovascular Health of Older Adults and Resveratrol (CORE) (CORE)
Cardiovascular Health of Older Adults and Resveratrol
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Florida
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Gainesville、Florida、美国、32610
- University of Florida
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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);
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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)
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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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Placebo
Alike looking 1 pill 3 times per day
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Speckle tracking analyses
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Flow-mediated dilation
大体时间: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)
大体时间: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
大体时间: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
大体时间:Change from baseline and 3 months
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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)
大体时间:Change from baseline and 3 months
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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.
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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 Enzyme-linked immunosorbent assay (ELISA)
大体时间:Change from baseline and 3 months
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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
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Autophagy measured by Western Blot
大体时间:Change from Baseline and 3 months
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Autophagy 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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合作者和调查者
调查人员
- 首席研究员:Robert T Mankowski, Ph.D.、University of Florida
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB201601756
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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