- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02909699
Cardiovascular Health of Older Adults and Resveratrol (CORE) (CORE)
Cardiovascular Health of Older Adults and Resveratrol
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Florida
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Gainesville, Florida, Stati Uniti, 32610
- University of Florida
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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);
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Speckle tracking analyses
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Flow-mediated dilation
Lasso di tempo: 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.
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Change from baseline and 3 months
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Autophagy measured by Enzyme-linked immunosorbent assay (ELISA)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Robert T Mankowski, Ph.D., University of Florida
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IRB201601756
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Observation
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Fondazione Don Carlo Gnocchi OnlusIstituto di Neuroscienze Consiglio Nazionale delle RicercheReclutamento
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IRCCS Eugenio MedeaMassachusetts Institute of Technology; Politecnico di MilanoCompletatoDisturbo dello spettro autisticoItalia