Cardiovascular Health of Older Adults and Resveratrol (CORE) (CORE)
Cardiovascular Health of Older Adults and Resveratrol
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Florida
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Gainesville、Florida、アメリカ、32610
- University of Florida
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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);
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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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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Speckle tracking analyses
時間枠: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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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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Flow-mediated dilation
時間枠: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)
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
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Autophagy measured by Western Blot
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Robert T Mankowski, Ph.D.、University of Florida
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
- IRB201601756
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?
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