Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Reducing Cardiovascular Risks: The Role of Alcohol Use

20 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

148

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Altro: 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.
Sperimentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in in-laboratory central and peripheral blood pressure
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in arterial stiffness
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective sleep
Lasso di tempo: During the study participation (10 weeks).
A longitudinal assessment of objective sleep will be performed with Oura rings.
During the study participation (10 weeks).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Texas at Arlington

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 agosto 2031

Completamento dello studio (Stimato)

1 settembre 2031

Date di iscrizione allo studio

Primo inviato

14 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 agosto 2026

Primo Inserito (Effettivo)

24 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-0383

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Criteri di accesso alla condivisione IPD

Submit a Data Access Request to NDA and get approval.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

Sottoscrivi