CONSUME: The Effects of Alcohol Consumption on Central Adiposity

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT03521817
Collaborator
Ursula A. White (Other), Frank L. Greenway (Other), Corby K. Martin (Other)
12
1
2
17.6
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Alcohol
  • Other: No Alcohol
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Alcohol Consumption on Central Adiposity and Testosterone Following Weight Loss in Obese, Pre-menopausal Women
Actual Study Start Date :
May 18, 2018
Actual Primary Completion Date :
Nov 4, 2019
Actual Study Completion Date :
Nov 4, 2019

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Central (Abdominal) Adiposity [8 weeks]

      change in visceral abdominal adipose tissue from baseline to post intervention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center
    • Ursula A. White
    • Frank L. Greenway
    • Corby K. Martin

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    John Apolzan, Assistant Professor, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT03521817
    Other Study ID Numbers:
    • 2017-057
    First Posted:
    May 11, 2018
    Last Update Posted:
    Jun 17, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Alcohol No Alcohol
    Arm/Group Description 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). 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. 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). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
    Period Title: Overall Study
    STARTED 7 5
    COMPLETED 7 4
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Alcohol No Alcohol Total
    Arm/Group Description 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). 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. 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). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol Total of all reporting groups
    Overall Participants 7 5 12
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    7
    100%
    5
    100%
    12
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    32
    (9)
    31
    (7)
    32
    (8)
    Sex: Female, Male (Count of Participants)
    Female
    7
    100%
    5
    100%
    12
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    28.6%
    1
    20%
    3
    25%
    White
    4
    57.1%
    4
    80%
    8
    66.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    14.3%
    0
    0%
    1
    8.3%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Alcohol No Alcohol
    Arm/Group Description 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). 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. 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). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
    Measure Participants 7 3
    Mean (Standard Error) [kg]
    -0.250
    (0.115)
    -0.071
    (0.075)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Alcohol, No Alcohol
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.231
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.18
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.14
    Estimation Comments

    Adverse Events

    Time Frame From baseline to completion of study 8 weeks later. Furthermore follow-up calls and emails (not in person visits) were performed post study. Thus total period of time adverse event data were collected was 12 weeks.
    Adverse Event Reporting Description
    Arm/Group Title Alcohol No Alcohol
    Arm/Group Description 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). 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. 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). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
    All Cause Mortality
    Alcohol No Alcohol
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/7 (0%) 0/5 (0%)
    Serious Adverse Events
    Alcohol No Alcohol
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/7 (0%) 0/5 (0%)
    Other (Not Including Serious) Adverse Events
    Alcohol No Alcohol
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/7 (14.3%) 2/5 (40%)
    Respiratory, thoracic and mediastinal disorders
    Sinus Congestion 0/7 (0%) 0 1/5 (20%) 1
    Upper respiratory complaints (cold) 1/7 (14.3%) 1 0/5 (0%) 0
    Skin and subcutaneous tissue disorders
    Pruritis (itching) 0/7 (0%) 0 1/5 (20%) 1

    Limitations/Caveats

    One additional person was randomized due to a participant dropout.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title John W Apolzan
    Organization Pennington Biomedical Research Center
    Phone 225-763-2827
    Email john.apolzan@pbrc.edu
    Responsible Party:
    John Apolzan, Assistant Professor, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT03521817
    Other Study ID Numbers:
    • 2017-057
    First Posted:
    May 11, 2018
    Last Update Posted:
    Jun 17, 2020
    Last Verified:
    Jun 1, 2020