The Effects of Alcohol Consumption on Central Adiposity

Study Overview
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Brief Summary
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The objective of the proposed study is to enroll women with obesity that will undergo a controlled, energy restricted feeding intervention to test the effects of chronic ethanol consumption on adipose distribution and circulating testosterone during weight loss.

Detailed Description
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Alcohol (i.e. ethanol) is one of the most widely used recreational substances by humans and is consumed regularly by much of the U.S. population. Despite the high prevalence of alcohol intake, the metabolic health effects associated with use have not been firmly established. There is a paucity of data from longitudinal studies in humans that examine the metabolic response to routine alcohol consumption in a randomized controlled trial (RCT). This is a novel pilot study to examine, for the first time, the effects of ethanol consumption on fat distribution and testosterone during weight loss in a RCT. Findings from this study would provide insight into an interesting and unanswered question -- does routine alcohol intake exert unfavorable health effects despite the expected beneficial outcomes of caloric restriction and weight loss? This research may provide new knowledge of the metabolic outcomes resulting from alcohol intake and pathways that may be involved leading to potential new therapeutic targets of treatment. The objective of the proposed study is to enroll women with obesity that will undergo a controlled, energy restricted feeding intervention to test the effects of chronic ethanol consumption on adipose distribution and circulating testosterone during weight loss. Women will be randomized to an ethanol-free control group or an ethanol-consuming group, and all will consume 30% energy-restricted diets.

Official Title
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The Effects of Alcohol Consumption on Central Adiposity and Testosterone Following Weight Loss in Obese, Pre-menopausal Women

Conditions
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Alcohol Drinking, Weight Loss, Adiposity, Obesity, Visceral Obesity

Intervention / Treatment
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* Other: Alcohol
* Other: No Alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Pre-menopausal women only 21-40 years of age BMI 27-50 kg/m2 (+/- 0.5 will be accepted) Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, intrauterine contraceptive devices, tubal ligation (surgically sterile), abstinence, or in an established relationship with a vasectomized or same sex partner) during the entire duration of the study Must be willing to adhere to all study procedures, including consumption of all study foods and beverages and attendance at all study visits - Must be willing to eat at least one meal at PBRC 3 times per week on weekdays (excluding holidays) Must be willing to consume alcohol Must be willing to abstain from alcohol for 8-weeks if randomized to non-alcohol control group. Must be a daily, or almost daily drinker, defined as typically consuming at least 8 drinks per week, but no more than 4 per day Must be willing to undergo an overnight alcohol test (at home) of ethanol at the proposed dose before enrollment in the study Must have access to a device that can be used for video monitoring of compliance (i.e. Skype) Must be willing to have your blood stored for future research Exclusion Criteria: - Non-drinkers of alcohol Habitual binge drinkers, as defined by the consumption of ≥ 4 standard drinks per day or ≥ 28 drinks per week. Self-reported alcoholics or a history of alcoholism Have a 1st degree relative with alcoholism Any attendance or inpatient stay for alcohol or drug treatment Display any characteristics of current or future substance abuse disorders Presence of any psychiatric, behavioral, or medical disorder that, in the opinion of the PIs, Co-I, or MI, may interfere with study participation, the ability to adhere to the protocol, or has the potential for increased substance abuse Prescription medications that interact with alcohol intake Abnormal screening laboratory safety tests Smokers Diagnosis of Type 1 or 2 diabetes mellitus, cancer, or major organ disease Serious digestive disorders Conditions that affect metabolism or body weight (i.e. uncontrolled thyroid conditions, bariatric surgery, pregnancy, breastfeeding) Partial and/or full hysterectomy Hormonal pharmaceutical contraceptives including oral contraception (birth control pills), injectables (Depo-Provera), or the patch (Xulane) PCOS Use of medications that affect body weight or metabolism (i.e. atypical antipsychotics, weight loss medications). Not willing to store biospecimens for future use

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

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
Interventional Model Description: This is a between-subjects parallel study design. All women will undergo a 30% energy restriction for 8-weeks and will be randomized to an ethanol-consuming group or a non-ethanol control group at the start of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol<br>Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the  240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include  2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). | Other: Alcohol<br>* The ethanol group will consume a 30% energy restriction diet that will also include  2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one standard drink contains roughly 14 grams of pure alcohol.<br>* Other names: Etoh;|
| Active Comparator: No Alcohol<br>No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat). | Other: No Alcohol<br>* This group will not consume alcohol. Thus 0 kcal/d will come from alcohol<br>* Other names: No Etoh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central (Abdominal) Adiposity | change in visceral abdominal adipose tissue from baseline to post intervention | 8 weeks |