Reducing Cardiovascular Risks: The Role of Alcohol Use
20 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
148
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Chueh-Lung Hwang, PhD, PT
- Numéro de téléphone: 8172729722
- E-mail: chuehlung.hwang@uta.edu
Lieux d'étude
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Texas
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Arlington, Texas, États-Unis, 76010
- Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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.
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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.
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in in-laboratory central and peripheral blood pressure
Délai: Baseline and after the 8-week intervention
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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.
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Baseline and after the 8-week intervention
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Change in nighttime central and peripheral blood pressure
Délai: Baseline and after the 8-week intervention
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Blood pressure during nighttime (or sleep) will be measured by using a portable blood pressure monitor.
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Baseline and after the 8-week intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in arterial stiffness
Délai: Baseline and after the 8-week intervention
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Carotid to femoral pulse wave velocity (cfPWV), the gold standard for noninvasive arterial stiffness assessment, will be measured.
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Baseline and after the 8-week intervention
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Change in endothelial function as measured by brachial artery flow-mediated dilation (FMD)
Délai: Baseline and after the 8-week intervention
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Brachial artery flow-mediated dilation (FMD), a noninvasive measure of endothelial function, will be assessed using ultrasound.
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Baseline and after the 8-week intervention
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Change in muscle sympathetic nerve activity (MSNA)
Délai: Baseline and after the 8-week intervention
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Muscle sympathetic nerve activity (MSNA) in the leg will be measured at rest using microneurography, a direct invasive assessment of sympathetic neural outflow.
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Baseline and after the 8-week intervention
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Objective sleep
Délai: During the study participation (10 weeks).
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A longitudinal assessment of objective sleep will be performed with Oura rings.
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During the study participation (10 weeks).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
1 août 2031
Achèvement de l'étude (Estimé)
1 septembre 2031
Dates d'inscription aux études
Première soumission
14 août 2026
Première soumission répondant aux critères de contrôle qualité
20 août 2026
Première publication (Réel)
24 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-0383
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Description du régime 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.
Critères d'accès au partage IPD
Submit a Data Access Request to NDA and get approval.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .