Alcohol DrinkingCONSUMENCT03521817
The Effects of Alcohol Consumption on Central Adiposity
A study testing Alcohol and No Alcohol in people with Alcohol Drinking and Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Weight Loss, Adiposity
- What is being tested?
- Alcohol and No Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2018to 4 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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)
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- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Drinking, Weight Loss, Adiposity, Obesity, Visceral Obesity
- Being tested
- Alcohol, No Alcohol
- Medical subject headings
- Alcohol Drinking, Weight Loss, Obesity, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholOther
Also called Etoh
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 AlcoholOther
Also called No Etoh
This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: No Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central (Abdominal) Adiposity
change in visceral abdominal adipose tissue from baseline to post intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start18 May 2018
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ursula A. White, Frank L. Greenway, Martin, Corby, K., M.D.
- Responsible party
- Principal investigator, John Apolzan, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521817
- Sponsor's protocol ID
- 2017-057
- Acronym
- CONSUME
- Status last verified
- Jun 2020
- First submitted
- 29 Apr 2018
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Alcohol Consumption on Central Adiposity and Testosterone Following Weight Loss in Obese, Pre-menopausal Women
- ClinicalTrials.gov ID
- NCT03521817
- Acronym / sponsor ID
- CONSUME / 2017-057
- Conditions
- Alcohol Drinking, Weight Loss, Adiposity, Obesity, Visceral Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Ursula A. White, Frank L. Greenway, Martin, Corby, K., M.D.
- Study start
- 18 May 2018 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Posted 17 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alcohol | Experimental | Other: AlcoholEtoh 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 Alcohol | Active comparator | Other: No AlcoholNo 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). |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- - 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
Key exclusion criteria (18 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholAlso: EtohThe 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 | Alcohol |
| No AlcoholAlso: No EtohThis group will not consume alcohol. Thus 0 kcal/d will come from alcohol | Other | No Alcohol |
Primary outcome
Change in Central (Abdominal) Adiposity
Time frame: 8 weeks
change in visceral abdominal adipose tissue from baseline to post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol and No Alcohol in people with Alcohol Drinking and Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Central (Abdominal) Adiposity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.