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Reducing Blood Pressure in Mid-life Adult Binge Drinkers

Primary Purpose

Alcohol Drinking, Binge Drinking, Blood Pressure

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Training

Alcohol Abstinence Intervention

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring Exercise training, High-intensity interval training, Midlife adults, Middle-aged, Microvascular function, Sympathetic nerve activity

Eligibility Criteria

50 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of Texas at ArlingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Exercise Group

Non-exercise Group

Alcohol abstainer/moderate drinker group

Arm Description

Binge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment.

Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.

Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.

Outcomes

Primary Outcome Measures

Feasibility of high-intensity interval training

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 Outcome Measures

Changes in microvascular function

A 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 activity

A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min).

Changes in urine catecholamine levels

Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g)

Changes in blood pressure

Systolic and Diastolic blood pressure will be measured at rest and for 24 hours.

Changes in alcohol intake

Questionnaires will be used to determine alcohol intake.

Full Information

NCT ID

NCT05522075

First Posted

August 22, 2022

Last Updated

December 22, 2022

Sponsor

The University of Texas at Arlington

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT05522075

Brief Title

Reducing Blood Pressure in Mid-life Adult Binge Drinkers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 21, 2022 (Actual)

Primary Completion Date

October 30, 2024 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas at Arlington

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise Group

Arm Type

Experimental

Arm Description

Binge drinkers who have been assigned to exercise group will receive baseline assessment, 8-week exercise training plus alcohol abstinence intervention, and post-intervention assessment.

Arm Title

Non-exercise Group

Arm Type

Active Comparator

Arm Description

Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment.

Arm Title

Alcohol abstainer/moderate drinker group

Arm Type

No Intervention

Arm Description

Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention.

Intervention Type

Behavioral

Intervention Name(s)

Exercise Training

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Alcohol Abstinence Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility of high-intensity interval training

Description

Time Frame

Through out the study participation (~3 months)

Secondary Outcome Measure Information:

Title

Changes in microvascular function

Description

A 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.

Time Frame