Health TrialsbyHealthPanel

Reducing Blood Pressure in Mid-life Adult Binge Drinkers

ConditionsAlcohol DrinkingBinge DrinkingBlood PressureAlcohol AbstinenceAgingLifestyle FactorsVasodilationBehavioral Problem
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-64
SponsorThe University of Texas at Arlington

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Training

    Behavioral

    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.

  • Alcohol Abstinence Intervention

    Behavioral

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

Treatment groups

55 Participants
are divided into 3 treatment groups
Group A: Exercise GroupExperimental treatment 2 interventions
Group B: Non-exercise GroupActive comparator 1 intervention
Group C: Alcohol abstainer/moderate drinker groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through out the study participation (~3 months)

Secondary outcomes

1

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.

Time frame
Baseline and after an 8-week intervention
2

Changes in sympathetic activity

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

Time frame
Baseline and after an 8-week intervention
3

Changes in urine catecholamine levels

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

Time frame
Baseline and after an 8-week intervention
4

Changes in blood pressure

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

Time frame
Baseline and after an 8-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas at Arlington

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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