N/A
N=12
The Effects of Alcohol Consumption on Central Adiposity
Alcohol Drinking · Weight Loss · Adiposity · Obesity · Visceral Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03521817 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Change in Central (Abdominal) Adiposity — -0.250; -0.071 kg — p=<0.231
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alcohol (Other); No Alcohol (Other)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Central (Abdominal) Adiposity |
-0.250; -0.071 | <0.231 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03521817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.