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Reducing Cardiovascular Risks: The Role of Alcohol Use

20 de agosto de 2026 atualizado por: The University of Texas at Arlington

The purpose of this study is to learn whether avoiding alcohol can improve heart and blood vessel health in adults who regularly drink alcohol and have high blood pressure. High blood pressure is a major risk factor for cardiovascular disease (CVD), including heart attack and stroke.

In this randomized, controlled trial, men and women aged 26 to 49 years who regularly consume alcohol and have high blood pressure will be assigned by chance to either stop drinking alcohol or continue their usual drinking habits for 8 weeks. Researchers will compare changes in blood pressure and other cardiovascular disease risk factors between the two groups.

The information gained from this study may help researchers and health care providers better understand the effects of alcohol consumption on cardiovascular health and whether alcohol abstinence can reduce heart disease risk, especially in adults with high blood pressure.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

The overarching objective is to determine the effect of alcohol abstinence on cardiovascular disease risks in individuals who consume alcoholic beverages over the recommended limits. After baseline assessment, participants will be randomly assigned to receive one of the interventions: either continue their usual drinking habits or to abstain from alcohol drinking. Before and after the 8-week intervention, blood pressure and sub-clinical cardiovascular disease risk factors (including arterial stiffness, endothelial function, and sympathetic nerve activity) will be measured. A longitudinal assessment of objective sleep will be performed throughout the study participation. Participants will be asked to maintain their diet and physical activity throughout the study.

Tipo de estudo

Intervencional

Inscrição (Estimado)

148

Estágio

  • Não aplicável

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.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Texas
      • Arlington, Texas, Estados Unidos, 76010
        • Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington

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

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion criteria

  • Men and women aged 26 to 49 years
  • At-risk drinkers who drink over the recommended limits, defined as those with PEth (≥20 ng/dL) or those with a U.S. Alcohol Use Disorders Identification Test (USAUDIT) score ≥8/7 for men/women
  • Elevated blood pressure or hypertension (systolic blood pressure: 120-160 mmHg and/or diastolic blood pressure 80-100 mmHg)

Exclusion criteria

  • History of CVD or cardiovascular events (e.g., stroke, myocardial infarction)
  • The presence of myocardial ischemia or arrhythmias with abnormal ECG and blood pressure during a clinically-supervised maximal graded exercise test
  • Hypertension (systolic >160 mmHg and diastolic >100 mmHg)
  • On more than one anti-hypertensive medication, or on other physician-prescribed medications (but not including oral contraceptives)
  • Major psychiatric disorders, including autism, ADHD, bipolar disorder, major depression, schizophrenia, and substance use disorders
  • Alcohol use disorder, PEth ≥400 ng/mL, or USAUDIT score ≥ 25
  • Current or history of any tobacco use in the past 6 months (including, but not limited to, cigarettes, e-cigarettes, hookah, Nicorette, snus and chewing tobacco)
  • Current or history of illicit and recreational drug use (more than 3 times in the past month and more than 15 times in their lifetime)
  • Diabetes type 1 & type 2 with fasting blood glucose ≥126 mg/dL
  • Presence of renal disease with a creatinine > 1.5 mg/dL
  • Presence of liver disease with liver enzymes > 3x the upper limits of normal
  • Anemia with a hemoglobin < 8 g/dL
  • Diagnosis of chronic inflammatory disease such as, but not limited to, cancer
  • Diagnosis of chronic autoimmune diseases such as, but not limited to lupus, multiple sclerosis, rheumatoid arthritis
  • Diagnosis of chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, lung cancer, and cystic fibrosis
  • Diagnosis of neurological diseases, including seizure disorders, Alzheimer's disease, Parkinson's disease, multiple sclerosis, stroke, traumatic brain injury, and peripheral neuropathies
  • Body mass index <18.5 or ≥40 kg/m2
  • Unstable body weight (>5% change during the past 6 months)
  • Obstructive sleep apnea
  • Night-shift work
  • Women who are pregnant (or intend to become pregnant while participating in study), breastfeeding, or postmenopausal

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

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Usual Drinking Habits (Control)
Participants will continue their usual alcohol consumption patterns during the study period and will be instructed not to change their lifestyle including alcohol use, diet, and habitual physical activity.
Outro: Control arm
Participants will be asked to maintain their usual lifestyle, including alcohol consumption, diet, and physical activity, and will not have access to their study data during the intervention. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to complete questionnaires on alcohol use, physical activity, and diet. At week 4, participants will complete a dried blood spot phosphatidylethanol (PEth) test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.
Experimental: Alcohol Abstinence Intervention
Participants will be instructed to abstain from alcohol for 8 weeks. Throughout the study period, participants will be asked to maintain their usual diet and level of physical activity and avoid making other lifestyle changes, except for abstaining from alcohol.
Comportamental: Alcohol Abstinence
Participants will be instructed to abstain from alcohol for 8 weeks and maintain their usual lifestyle, including diet and physical activity. One week before the intervention, participants will be provided with an Oura Ring and instructed to wear it throughout the study. Every two weeks, participants will meet virtually with the research team (approximately 45 minutes) to receive educational materials and personalized feedback based on phosphatidylethanol (PEth), sleep, and heart rate variability data to support alcohol abstinence. During these meetings, participants will also complete assessments of alcohol use, physical activity, and dietary intake. At week 4, participants will complete a dried blood spot PEth test. Participants will also receive weekly reminders by text message or email to ensure Oura Ring data are uploaded successfully.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in in-laboratory central and peripheral blood pressure
Prazo: Baseline and after the 8-week intervention
In-laboratory central blood pressure will be measured after a 10-min rest in supine position, while in-laboratory peripheral blood pressure will be measured after a 10-min rest in seated position.
Baseline and after the 8-week intervention
Change in nighttime central and peripheral blood pressure
Prazo: Baseline and after the 8-week intervention
Blood pressure during nighttime (or sleep) will be measured by using a portable blood pressure monitor.
Baseline and after the 8-week intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in arterial stiffness
Prazo: Baseline and after the 8-week intervention
Carotid to femoral pulse wave velocity (cfPWV), the gold standard for noninvasive arterial stiffness assessment, will be measured.
Baseline and after the 8-week intervention
Change in endothelial function as measured by brachial artery flow-mediated dilation (FMD)
Prazo: Baseline and after the 8-week intervention
Brachial artery flow-mediated dilation (FMD), a noninvasive measure of endothelial function, will be assessed using ultrasound.
Baseline and after the 8-week intervention
Change in muscle sympathetic nerve activity (MSNA)
Prazo: Baseline and after the 8-week intervention
Muscle sympathetic nerve activity (MSNA) in the leg will be measured at rest using microneurography, a direct invasive assessment of sympathetic neural outflow.
Baseline and after the 8-week intervention

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Objective sleep
Prazo: During the study participation (10 weeks).
A longitudinal assessment of objective sleep will be performed with Oura rings.
During the study participation (10 weeks).

Colaboradores e Investigadores

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

Patrocinador

The University of Texas at Arlington

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 (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de agosto de 2031

Conclusão do estudo (Estimado)

1 de setembro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

14 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de agosto de 2026

Primeira postagem (Real)

24 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-0383

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified participant data collected during this study will be submitted to the NIMH Data Archive (NDA). These data will be made available to qualified researchers for scientific research, educational purposes, and other research-related activities in accordance with NDA data access policies.

Critérios de acesso de compartilhamento IPD

Submit a Data Access Request to NDA and get approval.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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