The Effects of Alcohol Consumption on Central Adiposity (CONSUME)

The Effects of Alcohol Consumption on Central Adiposity and Testosterone Following Weight Loss in Obese, Pre-menopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Obesity; Weight Loss; Adiposity; Visceral Obesity
• Intervention / Treatment: Other: Alcohol; Other: No Alcohol

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcohol; Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the ~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila).	Other: Alcohol; The ethanol group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one "standard" drink contains roughly 14 grams of pure alcohol.; Other Names: Etoh
Active Comparator: No Alcohol; No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat).	Other: No Alcohol; This group will not consume alcohol. Thus 0 kcal/d will come from alcohol; Other Names: No Etoh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Central (Abdominal) Adiposity	change in visceral abdominal adipose tissue from baseline to post intervention	8 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Ursula A. White; Frank L. Greenway; Corby K. Martin

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Alcohol Drinking; Obesity; Weight Loss; Obesity, Abdominal; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 2017-057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No