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Cardiovascular Health of Older Adults and Resveratrol (CORE) (CORE)

2018年11月28日 更新者:University of Florida

Cardiovascular Health of Older Adults and Resveratrol

This study will investigate how resveratrol (phenol present in red grapes, wine and peanuts) can improve heart muscle function and ability of arteries to dilate in response to an increase in blood flow in adults 65 years of age and older. Additionally, investigators will look at how resveratrol can improve functioning of cells (cellular house-keeping) which can be related to cardiovascular function.

調査の概要

状態

完了

介入・治療

詳細な説明

Age-related declines in left ventricular function and endothelium-dependent vasodilation increase the risk for cardiovascular (CV) disease and premature death in older adults. Structural changes to the arterial wall and cardiac muscle are indicated as a cause and appear to be induced by age-related oxidative stress and inflammation and reduced levels of autophagy, the cellular "house-keeping system". Pre-clinical studies indicate that resveratrol (RSV), a polyphenol present mostly in grapes and red wine, may improve left ventricular cardiac muscle and endothelial vasodilator function. Although, RSV has been shown to induce autophagy and improve CV function in animals, evidence for its effects on the CV system in humans is lacking, and there is a need for clinical trials to better understand the effects of RSV on CV function in humans. Because older adults are most likely to have impairments in the central and peripheral CV systems, they represent an ideal population to test the effects of RSV on CV function. Therefore, the central hypothesis is that RSV supplementation will improve age-related left ventricular cardiac muscle function and arterial vasodilation in older adults (> 65 years). The participants will undergo 90 days of RSV treatment (n=12) (1,000mg/day), or (n=12) (1,500mg/day) or placebo (n=12). Before and after the intervention, investigators will non-invasively investigate left ventricular and arterial vasodilator function. Additionally, investigators will examine cardiac muscle damage and inflammatory biomarkers in blood and autophagy and endothelial function protein levels and in skeletal muscle to better understand molecular mechanisms that may underlie the hypothesized beneficial effects of RSV on cardiovascular health in older adults.

研究の種類

観察的

入学 (実際)

27

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Florida
      • Gainesville、Florida、アメリカ、32610
        • University of Florida

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年~99年 (高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Moderately functioning older adults.

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
Dose 1
1,000mg of resveratrol per day (1 pill 3 times per day). This ancillary study will be observational without drug administration.
In this trial, cardiovascular function will be measured without drug administration. The drug will be administered within the main trial.
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.
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.

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
Speckle tracking analyses
時間枠:Change from Baseline and 3 months
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.
Change from Baseline and 3 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Flow-mediated dilation
時間枠:Change from baseline and 3 months
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.
Change from baseline and 3 months
Autophagy measured by Enzyme-linked immunosorbent assay (ELISA)
時間枠:Baseline and 3 months
Autophagy will be measured using Enzyme-linked immunosorbent assay (ELISA), a test that uses antibodies and color change to identify a substance.
Baseline and 3 months
Endothelin-1 protein expression will be measured by Western Blot
時間枠:Change from baseline and 3 months
Endothelin-1 protein expression will be measured using Western Blot which is used to identify specific amino-acid sequences in proteins.
Change from baseline and 3 months
Endothelial function endothelial nitric oxide synthase (eNOS) will be measured by Western Blot
時間枠: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.
Change from baseline and 3 months
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
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
Autophagy measured by Western Blot
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年11月1日

一次修了 (実際)

2018年3月31日

研究の完了 (実際)

2018年3月31日

試験登録日

最初に提出

2016年9月13日

QC基準を満たした最初の提出物

2016年9月16日

最初の投稿 (見積もり)

2016年9月21日

学習記録の更新

投稿された最後の更新 (実際)

2018年11月29日

QC基準を満たした最後の更新が送信されました

2018年11月28日

最終確認日

2018年11月1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?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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