CONSUME: The Effects of Alcohol Consumption on Central Adiposity
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 |
---|---|---|
|
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
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:
|
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:
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Outcome Measures
Primary Outcome Measures
- Change in Central (Abdominal) Adiposity [8 weeks]
change in visceral abdominal adipose tissue from baseline to post intervention
Eligibility Criteria
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
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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
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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)
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Partial and/or full hysterectomy
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Hormonal pharmaceutical contraceptives including oral contraception (birth control pills), injectables (Depo-Provera), or the patch (Xulane)
-
PCOS
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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.- 2017-057
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
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
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 |
john.apolzan@pbrc.edu |
- 2017-057