Reducing Blood Pressure in Mid-life Adult Binge Drinkers

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Exercise Training
* Behavioral: Alcohol Abstinence Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>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. | Behavioral: Exercise Training<br>* 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.<br>Behavioral: Alcohol Abstinence Intervention<br>* Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.<br>|
| Active Comparator: Non-exercise Group<br>Binge drinkers who have been assigned to non-exercise group will receive baseline assessment, 8-week alcohol abstinence intervention, and post-intervention assessment. | Behavioral: Alcohol Abstinence Intervention<br>* Subjects will be asked to abstain from alcohol for 8 weeks. Education materials and bi-weekly consultations will be provided.<br>|
| No Intervention: Alcohol abstainer/moderate drinker group<br>Alcohol abstainer/moderate drinker will complete baseline assessment only and will not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through out the study participation ( 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after an 8-week intervention | 
| Changes in sympathetic activity | A small electrode will be inserted into the back of the knee to record nerve activity (bursts/min). | Baseline and after an 8-week intervention | 
| Changes in urine catecholamine levels | Urine samples will be collected for 24 hours to measure norepinephrine levels (ug/g) | Baseline and after an 8-week intervention | 
| Changes in blood pressure | Systolic and Diastolic blood pressure will be measured at rest and for 24 hours. | Baseline and after an 8-week intervention | 
| Changes in alcohol intake | Questionnaires will be used to determine alcohol intake. | Baseline and after an 8-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sympathetic nerve activity, Exercise training, High-intensity interval training, Midlife adults, Middle-aged, Microvascular function