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The Effects of Alcohol Consumption on Central Adiposity (CONSUME)

Primary Purpose

Alcohol Drinking, Weight Loss, Adiposity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alcohol

No Alcohol

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alcohol

No Alcohol

Arm 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).

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).

Outcomes

Primary Outcome Measures

Change in Central (Abdominal) Adiposity

change in visceral abdominal adipose tissue from baseline to post intervention

Secondary Outcome Measures

Full Information

NCT ID

NCT03521817

First Posted

April 29, 2018

Last Updated

June 2, 2020

Sponsor

Pennington Biomedical Research Center

Collaborators

Ursula A. White, Frank L. Greenway, Martin, Corby, K., M.D.

1. Study Identification

Unique Protocol Identification Number

NCT03521817

Brief Title

The Effects of Alcohol Consumption on Central Adiposity

Acronym

CONSUME

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

May 18, 2018 (Actual)

Primary Completion Date

November 4, 2019 (Actual)

Study Completion Date

November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

Ursula A. White, Frank L. Greenway, Martin, Corby, K., M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking, Weight Loss, Adiposity, Obesity, Visceral Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alcohol

Arm Type

Experimental

Arm Description

Arm Title

No Alcohol

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Other

Intervention Name(s)

Alcohol

Other Intervention Name(s)

Etoh

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

No Alcohol

Other Intervention Name(s)

No Etoh

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Central (Abdominal) Adiposity

Description

change in visceral abdominal adipose tissue from baseline to post intervention

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Effects of Alcohol Consumption on Central Adiposity

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