Recruiting

Reducing Cardiovascular Risks: The Role of Alcohol Use

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ClinicalTrials.gov IDNCT07783061

PhaseNA

Enrollment148

SponsorThe University of Texas at Arlington

Age26 Years – 49 Years

SexALL

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Conditions studied

Alcohol Drinking, Drinking Behavior, At-risk Drinking, Cardiovascular Risk Factor, High Blood Pressure

About this study

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.

Interventions

Behavioral: 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.
Other: 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.

Primary outcomes

Change in in-laboratory central and peripheral blood pressure (Baseline and after the 8-week intervention)
Change in nighttime central and peripheral blood pressure (Baseline and after the 8-week intervention)

Eligibility information

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

Study locations

Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington, Arlington, Texas 76010 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-12.