Clinical trial NCT03521817: The Effects of Alcohol Consumption on Central Adiposity
Official title: The Effects of Alcohol Consumption on Central Adiposity and Testosterone Following Weight Loss in Obese, Pre-menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Weight Loss
Adiposity
Obesity
Visceral Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Ursula A. White
name: Frank L. Greenway
name: Martin, Corby, K., M.D.
First posted: 2018-05-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Central (Abdominal) Adiposity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References: