Eligibility Details:
Inclusion Criteria:
- − Pre-menopausal women only
- 21-40 years of age
- BMI 30-50 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 breakfast at PBRC every weekday morning
- 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