The Effects of Alcohol Consumption on Central Adiposity

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03521817

Run by

Pennington Biomedical Research Center

People needed

12

Starts

2018-05-18

Expected to finish

2019-11-04

Last updated by the study team

2020-06-17

Who can join

Age: 21 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• - 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

You may not qualify if…

• - 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

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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