Reducing Cardiovascular Risks: The Role of Alcohol Use

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age26-49
SponsorThe University of Texas at Arlington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alcohol Abstinence

    Behavioral

    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.

  • Control arm

    Other intervention

    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.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Usual Drinking Habits (Control)Other 1 intervention
Group B: Alcohol Abstinence InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in in-laboratory central and peripheral blood pressure

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.

Time frame
Baseline and after the 8-week intervention
2

Change in nighttime central and peripheral blood pressure

Blood pressure during nighttime (or sleep) will be measured by using a portable blood pressure monitor.

Time frame
Baseline and after the 8-week intervention

Secondary outcomes

1

Change in arterial stiffness

Carotid to femoral pulse wave velocity (cfPWV), the gold standard for noninvasive arterial stiffness assessment, will be measured.

Time frame
Baseline and after the 8-week intervention
2

Change in endothelial function as measured by brachial artery flow-mediated dilation (FMD)

Brachial artery flow-mediated dilation (FMD), a noninvasive measure of endothelial function, will be assessed using ultrasound.

Time frame
Baseline and after the 8-week intervention
3

Change in muscle sympathetic nerve activity (MSNA)

Muscle sympathetic nerve activity (MSNA) in the leg will be measured at rest using microneurography, a direct invasive assessment of sympathetic neural outflow.

Time frame
Baseline and after the 8-week intervention

Other outcomes

1

Objective sleep

A longitudinal assessment of objective sleep will be performed with Oura rings.

Time frame
During the study participation (10 weeks).

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