Reducing Cardiovascular Risks: The Role of Alcohol Use
2026년 8월 20일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
148
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Chueh-Lung Hwang, PhD, PT
- 전화번호: 8172729722
- 이메일: chuehlung.hwang@uta.edu
연구 장소
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Texas
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Arlington, Texas, 미국, 76010
- Science and Engineering Innovation and Research Building (SEIR), University of Texas at Arlington
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in in-laboratory central and peripheral blood pressure
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in arterial stiffness
기간: 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)
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective sleep
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2031년 8월 1일
연구 완료 (추정된)
2031년 9월 1일
연구 등록 날짜
최초 제출
2026년 8월 14일
QC 기준을 충족하는 최초 제출
2026년 8월 20일
처음 게시됨 (실제)
2026년 8월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 20일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
IPD 공유 액세스 기준
Submit a Data Access Request to NDA and get approval.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .