Reducing Cardiovascular Risks: The Role of Alcohol Use
20. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
148
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Chueh-Lung Hwang, PhD, PT
- Telefonní číslo: 8172729722
- E-mail: chuehlung.hwang@uta.edu
Studijní místa
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Texas
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Arlington, Texas, Spojené státy, 76010
- Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Jiný: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in in-laboratory central and peripheral blood pressure
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in arterial stiffness
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Objective sleep
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. října 2026
Primární dokončení (Odhadovaný)
1. srpna 2031
Dokončení studie (Odhadovaný)
1. září 2031
Termíny zápisu do studia
První předloženo
14. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
20. srpna 2026
První zveřejněno (Aktuální)
24. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-0383
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Kritéria přístupu pro sdílení IPD
Submit a Data Access Request to NDA and get approval.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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