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

28 de novembro de 2018 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

27

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • University of Florida

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

65 anos a 99 anos (Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Moderately functioning older adults.

Descrição

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);

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Speckle tracking analyses
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Flow-mediated dilation
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Robert T Mankowski, Ph.D., University of Florida

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2016

Conclusão Primária (Real)

31 de março de 2018

Conclusão do estudo (Real)

31 de março de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

13 de setembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de setembro de 2016

Primeira postagem (Estimativa)

21 de setembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de novembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de novembro de 2018

Última verificação

1 de novembro de 2018

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB201601756

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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