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Reducing Blood Pressure in Mid-life Adult Binge Drinkers

Reducing Blood Pressure in Mid-life Adult Binge Drinkers: the Role of Microvascular Function and Sympathetic Activity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05522075
Enrollment
55
Registered
2022-08-30
Start date
2022-11-21
Completion date
2027-04-30
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Alcohol Abstinence, Alcohol Drinking, Behavioral Problem, Binge Drinking, Blood Pressure, Lifestyle Factors, Vasodilation

Keywords

Exercise training, High-intensity interval training, Midlife adults, Middle-aged, Microvascular function, Sympathetic nerve activity

Brief summary

This study has two phases: Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers. Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers

Detailed description

During phase 1, we will measure blood pressure, microvascular function, and sympathetic nerve activity (baseline assessment) in mid-life adult binge drinkers, alcohol abstainers, and moderate drinkers. Only mid-life adult binge drinkers will enter Phase 2 and be randomized to the exercise training group and non-exercise control group. After 8 weeks of intervention, we will re-measure blood pressure, microvascular function, and sympathetic nerve activity (post-intervention assessment) in mid-life adult binge drinkers.

Interventions

BEHAVIORALExercise Training

Subjects will be asked to perform exercise training (high-intensity interval training) under supervision, 3 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.

BEHAVIORALAlcohol Abstinence Intervention

Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.

Sponsors

The University of Texas at Arlington
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Men and women (50-64 years of age) who do not drink alcohol, who drink at moderate levels, or who binge drink * Female subjects will be postmenopausal (i.e., cessation of menses for ≥1 yr). * Subjects who can speak and understand English.

Exclusion criteria

* a history of diabetes, cardiovascular disease, liver, or renal disease * current or history of smoking and illicit drug use * blood pressure ≥160/100 mm Hg * other known traditional cardiovascular disease risks: obesity (BMI≥35 kg/m2), or hyperlipidemia (total cholesterol\>230 mg/dl and/or LDL cholesterol\>160 mg/dl) * active infection (in the past 2 months) * a history of seizures, cancer, or inflammatory disease (i.e., gout or rheumatoid) * unstable body weight (\>5% change during the past 6 months) * regular aerobic exercise training (i.e., they engage in 30 min of structured aerobic exercise at least 3 times per week) * current use of hormone replacement therapy (i.e., estrogen, progesterone, and testosterone)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of high-intensity interval trainingThrough out the study participation (~3 months)Recruitment capacity (e.g., how many subjects respond and enter to the study or reasons of refusal), resulting subject characteristics, the number of exercise session attended, and the number of dropouts

Secondary

MeasureTime frameDescription
Changes in microvascular functionBaseline and after an 8-week interventionA small amount of fat will be taken form the buttock. Small vessels will then be found in the fat and their sizes in response to various flows and chemical agents will be measured.
Changes in sympathetic activityBaseline and after an 8-week interventionA small electrode will be inserted into the back of the knee to record nerve activity (bursts/min).
Changes in urine catecholamine levelsBaseline and after an 8-week interventionUrine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)
Changes in blood pressureBaseline and after an 8-week interventionSystolic and Diastolic blood pressure will be measured at rest and for 24 hours.
Changes in alcohol intakeBaseline and after an 8-week interventionQuestionnaires will be used to determine alcohol intake.

Countries

United States

Contacts

CONTACTChueh-Lung Hwang, PhD
chuehlung.hwang@uta.edu8172729722
PRINCIPAL_INVESTIGATORChueh-Lung Hwang, PhD

University of Texas at Arlington

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026