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N/A N=12 Randomized Treatment

The Effects of Alcohol Consumption on Central Adiposity

Alcohol Drinking · Weight Loss · Adiposity · Obesity · Visceral Obesity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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