The Effects of Alcohol Consumption on Central Adiposity

NCT03521817 | Completed Results

• 1 other identifier: 2017-057
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Weight Loss; Adiposity; Obesity; Visceral Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Central (Abdominal) Adiposity

  change in visceral abdominal adipose tissue from baseline to post intervention

  8 weeks

Study Arms (2)

Alcohol

EXPERIMENTAL

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

No Alcohol

ACTIVE COMPARATOR

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

Interventions

Alcohol OTHER

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.

Also known as: Etoh

Alcohol

No Alcohol OTHER

This group will not consume alcohol. Thus 0 kcal/d will come from alcohol

Also known as: No Etoh

No Alcohol

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Pre-menopausal women only
• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Ursula A. White: collaborator
• Frank L. Greenway: collaborator
• Martin, Corby, K., M.D.: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Weight Loss; Obesity; Obesity, Abdominal

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

One additional person was randomized due to a participant dropout.

Results Point of Contact

• Title: John W Apolzan
• Organization: Pennington Biomedical Research Center

john.apolzan@pbrc.edu

225-763-2827

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 11, 2018
• Study Start: May 18, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: June 17, 2020
• Results First Posted: June 17, 2020

Record last verified: 2020-06

Locations

US (1)