The Effects of Alcohol Consumption on Central Adiposity and Testosterone Following Weight Loss in Obese, Pre-menopausal Women
Phase: NA
Conditions: Alcohol Drinking, Weight Loss, Adiposity, Obesity, Visceral Obesity
Sponsor: Pennington Biomedical Research Center

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PROJECT TITLE: 
The effects of alcohol consumption on central adiposity and 
testosterone following weight loss in obese, pre-
menopausal women
INVESTIGATORS:
   Principal Investigators: John W. Apolzan PhD and Ursula A. White PhD 
   Co-Investigator: Corby K. Martin PhD
   Medical Investigator: Frank L. Greenway M.D.
I.
BACKGROUND AND SIGNIFICANCE
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). 
II.
STUDY RATIONALE AND OBJECTIVES
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. 
III.
STUDY POPULATION AND ELIGIBILITY CRITERIA
a.
Subjects
−
We will enroll 12 participants (N=7 (Ethanol group) and N=5 (Control group)) 
using the inclusion and exclusion criteria described below. The Recruitment Core 
at Pennington Biomedical will recruit the women via listserv emails, community 
flyers, and health promotion events. We will recruit an ethnically diverse group 
based on the demographics of Baton Rouge.
b.
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
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−
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
c.
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
IV.
EXPERIMENTAL DESIGN AND METHODS
All study visits and clinic procedures will be conducted over the course of 1 year at 
Pennington Biomedical Research Center (PBRC) by trained nurses and research staff in 
accordance with standard operating and quality control procedures approved by PBRC’s 
Institutional Review Board (IRB). 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. 
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Table 1: Schedule of Study Events
Tests
SV
1
Pre-
Rand 
Visit
CV1
Intervention
wk 1- wk 8
CV 2 
(wk 8)
Informed Consent/Lifestyle 
Interview 
X
Height (SV1 only)/Metabolic 
Weight/BMI, Waist and Hip 
Circumference,  Pulse, and 
Blood Pressure
X
X
X
Alcohol-related questionnaires 
(The Short Alcohol Dependence 
Data, SASSI, MAST)
X
X 
Pedometer Distributed/Collected
X
X (Wk8)
Food Record/Washout 
Instructions
X
Food Record Compliance 
Check
X
Medical History/ Physical/ 
Medications
X
Medications/Adverse Event 
Report
X
X(wkly)
X
Fasting Blood Draw*
X†
X*
X*
Questionnaires (retrospective 
VAS)
X
X
MRI, 1H-MRS, FibroScan
X
X
Physical Activity (steps/day)
X
X
Alcohol Tolerance Test
X
Randomization
X
Controlled Feeding Dietary 
Intervention 
X
Body Weight 
X
CV, Clinic Visit; SASSI, Substance Abuse Subtle Screening Inventory; MAST, 
Michigan Alcoholism Screening Test; VAS, Visual Analogue Scale / † Chem 15, HCG / 
*Chem 26, insulin, free and total testosterone and archives
Study Visits
Screening Visit 1 (S1)
SV1 will be conducted the morning after a ~10-hr overnight fast. After acknowledging 
understanding of the study and all procedures, subjects will sign an informed consent. 
Demographics, vital signs, and medical history will be assessed. A physical exam will be 
administered. Anthropometric characteristics (i.e. height, metabolic weight, BMI, blood pressure, 
waist and hip circumference) will be measured. A blood sample will be collected for laboratory 
safety tests and menstrual cycle status will be determined. 
A semi-standardized Lifestyle (diagnostic) Interview will be administered by trained 
behavioral staff (Master’s Level Psychologists) and overseen by clinical psychologist and Co-
Investigator Corby Martin, Ph.D. The interviewer will investigate any current or lifetime 
prevalence of substance use and will identify and exclude for psychological co-morbidities that 
preclude participation in the study. Substance Abuse Subtle Screening Inventory (SASSI) and 
Michigan Alcoholism Screening Test (MAST) questionnaires will be administered. All 
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participants will be screened and excluded for the presences of diagnosable mood and/ or 
personality disorders that would interfere with the ability to adhere to protocol. Structured 
Clinical Interviews (SCID-5 and SCID-5 PD) are semi structured guides to interview that 
enhance and standardize diagnosis or evaluation of various psychological disorders. The SCID 
5 evaluates DSM 5 diagnoses, including mood disorders, psychotic symptoms, psychotic 
disorders substance use, etc.). The SCID 5 PD is an evaluation of 10 different personality 
disorders including: Avoidant Personality Disorder, Dependent Personality Disorder, Obsessive-
Compulsive Personality Disorder, Paranoid Personality Disorder, Schizotypal Personality 
Disorder, Schizoid Personality Disorder, Histrionic Personality Disorder, Narcissistic Personality 
Disorder, and Antisocial Personality Disorder. Test scores from the questionnaires will be 
thoroughly analyzed by Dr. Corby Martin and his team followed by a more detailed discussion 
with the subject. Participants that display any characteristics of substance abuse or mental 
disorders will be excluded. The interview will also ascertain barriers to participation in the study, 
including participants’ willingness to commit to the study, potential scheduling conflicts, support 
from household members to participate in the study, motivation and challenges facing the 
participant, details of the randomization and intervention, and other study-related issues of 
importance. This information will be used to identify and exclude from enrollment participants 
who will not be capable of completing the study. The results from the diagnostic interview will be 
used to provide an overall eligibility assessment for each candidate. A multidisciplinary team 
consisting of behavioral experts, dietitians, clinical staff, Medical Investigator (Frank Greenway, 
MD), and study staff will discuss and approve a candidate for official admission to the study. If 
eligible, the participants will undergo a Pre-Randomization Visit, which will include a mandatory 
one-night test of ethanol consumption at the proposed dose to assess alcohol tolerance.
Pre-Randomization Visit 
Before enrollment in the study, all women will be required to undergo an overnight 
alcohol tolerance test at the required ethanol dose. Participants will receive the required ethanol 
dose at the pre-randomization visit along with instructions for consumption. Participants will be 
monitored via video chat technology (Skype) by study staff from the time the person starts 
drinking to 1-2 hours after they have finished drinking the alcohol. For minor adverse events 
experienced by the subject, such as headache, nausea, diarrhea or other similar issue, that are 
conveyed to the study staff, one should call the medical investigator. In the unlikely event that 
the person experiences serious adverse events and becomes agitated and destructive, or 
otherwise being out of control and a danger to herself and others, or if the person becomes so 
sedated that she is no longer responding to conversation in the audio portion of the Skype and 
is becoming unconscious, these would be indications to call 911. Women will be instructed to do 
a one-week alcohol-free washout. Women will be administered a dietary record and step log 
(pedometer provided) and asked to return these completed items at Clinic Visit 1. Pending 
adherence to the overnight alcohol test, the one-week ethanol-free washout, and the return of a 
dietary record, participants will undergo Clinic Visit 1. 
Clinic Visit (CV) 1 and 2 
At CV1 and 2, women will report to PBRC after an overnight fast during the luteal phase 
of the menstrual cycle. Anthropometric characteristics will be measured. Body composition 
scans (MRI, 1H-MRS, and FibroScan) and blood draws (Chem 26, insulin, testosterone (free 
and total)) will be performed. A sample of blood (serum and plasma) will be collected for 
archive. The appetite questionnaire will be administered. Participants will be randomized to the 
control or ethanol group and begin the dietary intervention. 
8-Week Dietary Intervention
Participants will be provided all meals that are prepared by the PBRC metabolic kitchen 
(5-day meal rotation) and given both verbal and written instructions as to the consumption of the 
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food. On weekdays, at least one meal (i.e. breakfast, lunch, or dinner) will be consumed at 
PBRC 3 times per week, (excluding holidays), whereas the other weekday meals will be 
packaged for takeout. In addition, alcohol, weekend, and holiday meals will be packaged for 
takeout. Participants’ energy requirements will be determined from their estimated resting 
metabolic rate (RMR), calculated via the Mifflin-St. Jeor formula, with an activity factor of 1.5. 
The energy requirements will then be multiplied by 0.70 so that all participants will restrict 
energy needs by 30% compared to weight maintenance. Each group (control and ethanol) will 
have the same 30% reduction in calories and will consume the same percentage of each 
traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat). 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. 
Caloric differences between the spirits will be accounted for by being administered on specific 
days of the meal rotation so that the appropriate mixers are provided. The remaining calories 
(Mifflin-St. Jeor formula, with an activity factor of 1.5 multiplied by 0.70 minus the ~240 kcals 
from ethanol) will be consumed as 20% protein, 50% carbohydrate, and 30% fat. The control 
group will consume these ~240 kcal as included in the aforementioned macronutrient 
percentages (20% protein, 50% carbohydrate, and 30% fat).  
Participants will be asked to have an in-clinic check in once per week when coming for 
their in-house meal. At this check a metabolic weight will be obtained, adverse events and 
changes in medication will also be assessed. The ethanol group will be also be administered the 
alcohol-related questionnaires. 
Instructions for Alcohol Consumption
The alcohol will be treated with additional oversight and will be purchased, logged, 
handled, and dispensed by the PBRC pharmacist. Women randomized to the ethanol group will 
be provided detailed verbal and written instructions regarding the consumption of alcohol. 
Participants will be provided with a list of the specific types of alcohols that are permitted. 
Measured doses of alcohol will be prepared by the PBRC pharmacist. Sealed, individual bottles 
(~7) of alcohol will be dispensed to the participant once per week (Monday; excluding holidays) 
through PBRC clinic. Each bottle will contain a pre-measured dose of alcohol, and participants 
will drink one bottle per day of the week. The subject will be instructed to consume the alcohol 
over the course of a couple hours at home (not strictly before bedtime) so as not to interfere 
with important daily tasks and to avoid periods where it is necessary to drive. She will be given 
general information about alcohol and informed of the effects of its use on the body, including 
impaired coordination, judgment, alertness, and diminished quality of sleep. The participants will 
be warned of the risks associated with performing daily activities and operating vehicles or other 
machinery after alcohol ingestion. Subjects will also be provided information about the warning 
signs of alcohol dependency.
Dietary and Alcohol Compliance 
Compliance with consuming the study meals and alcohol will be monitored. The 
consumption of select meals and the ingestion of all alcoholic drinks will be monitored by study 
staff via video technology (e.g. Skype, cellular phone device) designed to quantify dietary 
compliance. A daily diary will be completed by the women each day to document the time and 
amount of the study alcohol consumption. This diary will be returned at the Monday clinic visit 
(excluding holidays). Participants will also complete a food and alcohol consumption log at the 
daily study visits. Subjects will be instructed to report if any additional food, beverages, and 
alcoholic drinks were consumed. Subjects who are under-compliant (<85%) or over-compliant 
(>100%) will be counseled by study staff on the importance of compliance. Repeated (i.e. >2 
events) under- or over-compliance will result in the participant being dropped from the study. 
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Body weight will be monitored weekly during the intervention. All collected data will be 
documented. Collectively, these methods will be implemented to enforce dietary compliance 
during the intervention.
Participant Safety
Subjects in the ethanol group will be closely monitored and frequently assessed 
throughout the study to identify any signs of alcoholism. A questionnaire (The Short Alcohol 
Dependence Data Questionnaire) will be administered weekly to evaluate the possibility of 
alcohol dependency. We will also re-administer the SASSI and MAST questionnaires. Study 
staff will verbally correspond with the participants weekly to assess any adverse events and 
ascertain any undesirable changes in mood or daily routine that may be associated with alcohol 
consumption. The Medical Investigator will have oversight through the duration of the study. 
If any participant exhibits signs of alcohol dependency issues during the study based on 
self-report or the weekly questionnaires, a more comprehensive assessment (i.e. interview) by 
trained study staff and the medical investigator will be done. The subject will be withdrawn from 
the study and referred to a substance abuse center for treatment.
At the end of the intervention, participants will be contacted (phone) by trained study 
staff at 2 weeks and 4 weeks after completion of the study in order to assess if the women have 
acquired any alcohol abuse and/or dependency issues. If the subject exhibits any alcohol-
related issues, she will be referred to a substance abuse center for treatment.
Study Procedures
Blood Draws: Blood will be collected at screening (Chem15, HCG), as well as at Clinic 
Visit 1 and Clinic Visit 2 (Chem26 + insulin, testosterone (free and total)). Blood (serum and 
plasma) will also be archived at the CV1 and CV2 time points. 
Magnetic Resonance Imaging (MRI): scABD AT and VAT volumes will be defined and 
quantified with magnetic resonance imaging (MRI) using a 3.0T scanner (GE, Discovery 750w) 
by obtaining ~581 images from the dome of the liver to the pubic symphysis. Images will be 
analyzed by a single trained analyst.
1H-Magnetic Resonance Spectroscopy (MRS): Intrahepatic lipid will be measured by 1H-
MRS on a 3.0T whole body imaging and spectroscopy system (GE, Discovery 750w) with a 
commercially available 1H body coil. IHL content will be determined with jMRUI (Java-Based 
Magnetic Resonance User Interface), and IHL peak areas will be expressed relative to the peak 
area of an external phantom of known constant concentration (peanut oil signal).
FibroScan: Liver assessments will be obtained using a FibroScan ultrasound transient 
elastography device. The participant lies supine, a lubricating gel is applied to the skin at the 
level of the liver, and a hand-held probe is pressed against the gel as is done in a traditional 
liver ultrasound exam. Ultrasound images of the liver are obtained, guided by the FibroScan 
user interface. From these images, quantitative measurements of liver fat content and stiffness 
are obtained and uploaded to the study database.  The procedure takes ~20 minutes. 
The FibroScan procedure can identify clinically-significant levels of liver fibrosis and/or 
steaosis. A result deemed significant by the medical investigator of this study will trigger a 
clinically actionable incidental finding. 
Radioimmunoassay (RIA): Testosterone levels will be measured by standard 
radioimmunoassay reagent sets.
Physical Activity: We will collect physical activity data with a pedometer to determine the 
number of steps per day. 
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Appetite Questionnaire: Retrospective Visual Analogue Scale (RVAS) will be used to 
measure average ratings of appetitive sensations that participants experienced over the past 
week (17,18). This validated method of collecting VAS data has been found to be consistent 
with daily assessments of satiety. 
V.
POTENTIAL RISKS AND BENEFIT ASSESSMENT
The known risks, inconveniences, or side effects from the proposed procedures in the project 
are shown in Table 2. 
Table 2. Potential Risks and Efforts to Minimize the Risks to Human Subjects
Procedure
Potential Risks
Efforts to Minimize the Risks
Ethanol 
(alcohol) 
Consumption
Alcohol intake is associated with a 
variety of health risks, including high 
blood pressure, liver disease, impaired 
cognitive function, weakened immune 
system, and certain types of cancers. 
Other risks include drowsiness, 
malaise, mood and behavior changes, 
depression, headaches, impaired 
coordination and judgment, and the 
potential for addiction and 
dependency. Drinking alcohol also 
increases the risk of short-term harms, 
including motor vehicle accidents and 
injuries. 
Before enrolling in the study, 
several measures will be 
conducted to minimize risks 
including the following: stringent 
inclusion/exclusion criteria; SASSI 
and MAST substance abuse 
screening questionnaires, a 
diagnostic interview by a trained 
behavioral psychologist, and an 
overnight alcohol test. Additional 
safeguards and alcoholism 
screening tools will be 
implemented frequently 
throughout the duration of the 
study. To reduce the risks of 
alcohol-related harms, participants 
will be instructed to consume the 
alcohol over the course of a 
couple hours at home (not strictly 
before bedtime) and not while 
driving or operating machinery. 
Participants will also report any 
adverse events or undesirable 
changes in mood or behavior 
throughout the duration of the 
study. Participants will be 
monitored for non-compliance, as 
the consumption of additional 
alcoholic drinks beyond what is 
required for the study may 
exacerbate the risks associated 
with alcohol use.
Blood Draws 
(Fasting)
Bruising, bleeding, pain, and infection 
pose minimal risks.
Trained phlebotomists and 
personnel will use sterile 
technique.
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Magnetic 
Resonance 
Imaging 
(MRI) and 
Spectroscopy 
(MRS)
There are no known biological risks 
associated with magnetic resonance 
scanning. There is a minimal risk for 
side effects, such as feelings of 
claustrophobia or muscle-skeletal 
discomfort from lying partially in the 
magnet for up to 45 minutes. There 
may also be loud, unpleasant noise. 
The magnetic field can move any 
metallic objects and disrupt the 
function of certain electronic devices 
that are inside the body. The long-term 
risk of exposure to a magnetic field is 
unknown, but considered extremely 
low.
Pillows will be used to ensure 
comfort during the testing. 
Earplugs or headphones are 
provided to reduce the noise. 
Certain implants, electronic 
devices, or any other foreign 
metallic objects in the body will not 
be permitted.
FibroScan
There may be minor discomfort from 
the application of the gel and pressure 
on the skin from the Fibroscan probe. 
However, there are no known health 
risks associated with the FibroScan.
Confidentiality 
of Data
Taking part in this research may 
involve providing information that one 
considers confidential or private. There 
is a slight risk that data could be 
revealed inappropriately or accidentally
Study researchers and staff will 
take steps to protect data that is 
collected. Efforts, such as coding 
research records, keeping 
research records secure and 
allowing only authorized people to 
access research records, will be 
made to keep the data safe.
The SCID-5, SCID-NP, SASSI, 
and MAST data will not be stored 
in Medical Records. Rather, this 
information will be stored in locked 
file cabinets in the Ingestive 
Behavior Laboratory, which is 
under the directorship of Dr. 
Martin,who will supervise the 
delivery of these instruments and, 
in collaboration with the Medical 
Investigator, Dr. Greenway, 
interpret the instruments.
Archive of 
Biological 
(Blood) 
Sample
The primary risk to participants who 
have blood banked for future research 
is the risk of loss of confidentiality 
and/or privacy.  These blood samples 
will be stored indefinitely.  The 
samples may be given to other 
investigators for future research as 
well.  The future research may not take 
For privacy and confidentiality, the 
biospecimens will be labeled with 
a unique series of letters and 
numbers.  The research done with 
the specimens may help to 
develop new products in the 
future, or may be used to establish 
a cell line or test that could be 
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place at Pennington Biomedical 
Research Center and may not be 
reviewed by Pennington Biomedical 
Research Center’s Institutional Review 
Board.
patented or licensed.  Subjects will 
not receive any financial 
compensation for any patents, 
inventions or licenses developed 
from this research.  Storage and 
disposal of biospecimens will be 
conducted in a manner conforming 
to the appropriate care and 
handling of biological specimens 
as outlined through the 
Institutional Biohazard Committee 
Guidelines.  
Protection Against and Minimizing Risks. While there are some potential risks for the 
proposed study, the design makes every attempt to prevent the possibility of any adverse 
events by the activities listed in Table 2, last column. Monitoring by the experienced 
investigators and professionals involved in the study will minimize all potential risks. By 
mitigating the potential risks, the risks that are associated with the proposed procedures are 
less than the potential benefits to be gained by the participants.  
Potential Benefits to Human Subjects.
Benefits. Subjects will undergo an 8-week, 30% calorie-restricted feeding intervention 
that will result in substantial weight loss and potential improvements in metabolic health. 
Participants will also receive important information about their health (i.e. adipose tissue 
distribution and insulin sensitivity).
Compensation for participation. After completion of the study, participants will be 
compensated $250. Subjects that do not complete the entire study will be compensated $50 for 
the successful completion of CV1, $100 for the successful completion of the intervention, and 
$100 for the successful completion of CV2.The total $250 is determined according to standard 
policies for procedures done at PBRC.
Data Collection, Storage and Subject Confidentiality.
Protection of Subject Privacy and Stored Data. Protection of subject privacy will be 
accomplished by a variety of stringent security measures. Physical examinations will occur in an 
enclosed, private area. All health history and exam results will also be discussed in a private 
area. All medical records will be stored in locked areas, and access to these areas is limited to 
the clinic support staff, the Director of the clinical facilities, PIs at PBRC, and authorized 
designees of the PI. Volunteer medical records will be filed according to an assigned volunteer 
ID number. Further, the SCID-5, SCID-NP, SASSI, and MAST data will not be stored in Medical 
Records. Rather, this information will be stored in locked file cabinets in the Ingestive Behavior 
Laboratory, which is under the directorship of Dr. Martin who will supervise the delivery of these 
instruments and, in collaboration with the Medical Investigator, Dr. Greenway, interpret the 
instruments. This process is in place to prevent the unintended release of psychological 
information should a copy of a participant’s medical records be requested. The only people who 
will know that these patients are research participants are members of the research team. No 
information about them, or provided by them during the research, will be disclosed to others 
without their written permission, except if it is necessary to protect their rights or welfare (for 
example, in case of injury or emergency care), or if it is required by law. When the results of the 
research are published or discussed in conferences, no information will be included that would 
reveal the identity of the individuals. Participants will be identified by codes when the data 
gathered in this procedure is presented or published. Authorized representatives of the NIH may 
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need to review records of individual participants. As a result, they may see their name; but they 
are bound by rules of confidentiality not to reveal the participants’ identity to others.  Electronic 
data is stored in a secured Microsoft SQL database. Only authorized IT personnel in Computing 
Services have access to the database.
Database Protection. Electronic data storage is secured with password protection and 
similarly restricted with only the PI and authorized persons having access to databases 
containing confidential clinical records, i.e. those containing name or other identifying 
information. Electronic communication will involve only unidentifiable information.     
Participant confidentiality. PBRC complies with the federal 1996 Health Insurance 
Portability and Accountability Act (HIPAA). Specifically, PBRC protects the privacy and 
confidentiality of medical records and information contained in medical records of persons who 
are subjects of research projects, including all protected health information (PHI) as defined by 
the HIPAA privacy Regulations. PHI of research subjects and the use or disclosure of such 
information is governed by PBRC research policies as well as Common Rule, FDA regulations, 
and other applicable laws. 
PBRC and study PIs (the persons chiefly responsible for the record) protect the privacy 
of research subjects and their PHI collected during a research project. PBRC will not use or 
disclose existing PHI or PHI created during a research project, unless the:

Subject signs both (a) a HIPAA Authorization for use and disclosure of PHI using an 
approved Authorization Form or other form containing all the elements of legally effective 
HIPAA authorization; and (b) the informed consent to participate in research form 
approved by IRB; or

IRB grants a waiver to the requirement of obtaining a signed HIPAA authorization Form, 
or

IRB approved protocol uses properly de-identified PHI
All participants are assured of their anonymity and confidentiality both verbally and in the 
informed consent.
Data and Safety Monitoring Plan (DSMP)
-
Description – The DSMP has been developed to provide ongoing oversight and 
monitoring of the proposed study to ensure and maintain: 
a) The scientific validity and integrity of the data so that new unbiased scientific 
knowledge is obtained 
b) Protocol compliance
c)
The safety of the participants (The study staff will remain in contact with the 
participants throughout the study. The participants will have the PIs’ and study 
coordinator’s work telephone number and the after-hours number to allow 
participants to contact them in case of an emergency.)
-
Data and Safety Monitoring committee - A local group of scientists at the Pennington 
Biomedical Research Center (PBRC) will perform the Data and Safety Monitoring 
(DSM). It includes: 
a.
Members of the Investigator team:
i.
The PIs: Ursula White, Ph.D. and John Apolzan, Ph.D. 
ii.
The study coordinator
iii.
The Medical Investigator: Frank Greenway, M.D.
iv.
The Bio-Statistician: Robbie Beyl, Ph.D. 
b.
Independent individuals who are not directly involved in the study: 
i.
Independent Monitor: TBD
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-
Meeting structure - These meetings will be open sessions, at which all committee 
members will be present. The main focus will be on accrual, protocol compliance, review 
of lab data and review of all AEs/SAEs. No outcome results will be discussed except 
after completion of the data collection. 
a.
The DSM committee will meet once every 3 months. (Note: An ad hoc meeting 
will be held with Dr. Greenway in case of a serious adverse event or death.) 
b.
Minutes will be recorded by the study coordinator and will be forwarded to all 
members of the committee. 
c.
The Independent Monitor will:
1.
Identify any deficiencies in the DSM plan and advise solutions
2.
Prepare a report reflecting the results of the reviews and 
discussion by the DSM committee. 
-
Data Quality and Management - The PI or study staff will review all data collection forms 
on an ongoing basis for data completeness and accuracy as well as protocol 
compliance.
 
-
Safety Monitoring
a) Study risk assessment - A description of the anticipated risks (i.e. adverse 
events) related to the procedures and efforts to minimize the associated risks are 
shown in Table 2 and will be included in the consent form.
b) Definitions
−
Adverse events (AE) are defined as expected adverse events if they are 
grade 2 and above in severity and unexpected side effect/events of any 
severity category. An adverse finding can include a sign, symptom, 
abnormal assessment (laboratory test value, vital signs, 
electrocardiogram finding, etc.) or any combination of these.
−
Serious Adverse Event (SAE) is any adverse event that results in one or 
more of the following outcomes:

Death

A life-threatening event

Inpatient hospitalization or prolongation of existing hospitalization 

A persistent or significant disability/incapacity

A congenital anomaly or birth defect

Important medical event based upon appropriate medical 
judgment
c)
Plan for AE detection and documentation
Flexible monitoring via interactive contacts
−
The study staff will remain in contact with the participants throughout the 
study. The participants will have the PI, Medical Investigator, and study 
coordinator’s work telephone number and the after-hours number to allow 
participants to contact them with questions or in case of an emergency 
related to the alcohol.    
Fixed visits 
−
At the start and end of the study, participants will come to the PBRC 
when routine biochemical blood tests are performed to exclude major 
pathology. In addition, the Medical Investigator or a designated 
physician’s assistant will meet with the participants monthly when they 
Pennington Biomedical IRB FWA 00006218
 
Approved March 6, 2019

12
Version Date: 02/11/19
come to give blood for measurement of liver enzymes. Any out of range 
lab values from these tests will be recorded and reported to the PI.  
AE documentation by the study coordinator
−Any event that is reported to either the PI or his designated research 
associates by the subject or medical staff caring for the subject which 
meets the criteria for an adverse event will be documented as such and 
graded as to its attribution (alcohol relatedness) and severity.
−Any serious adverse event that is fatal, immediately life-threatening or 
permanently (or significantly) disabling and requires hospitalization will be 
separately documented.     
d) Plan for AE reporting to IRB
Planned reporting at the regular DSM meetings. 
−
All AE will be reported to the DSM committee every six months. In 
addition, the lab results from each new subject and any abnormal liver 
enzyme values will be reported after consultation with our pharmacist who 
has the randomization codes. 
Serious AE reporting. 
−All serious adverse events will be immediately reported to the PIs. The 
PIs and designated research team will generate a serious adverse event 
report. The report will include a description of the event, when and how it 
occurred, as well as any official chart records or documentation to 
corroborate the event. 
−The serious adverse events will be reported to the Medical Investigator at 
an expedited ad hoc meeting.
−The report will be then immediately forwarded to the IRB (<5 days of the 
event).  
e) Annual safety reports. Based on the documentation from the DSM committee 
meetings compiled by the Independent Monitor, the study coordinator will 
prepare a report. A statement reflecting the results of the reviews with the 
Independent Monitor will be sent to the IRB. This report will include a list of 
adverse events and will address: (1) whether adverse event rates are consistent 
with pre-study assumptions; (2) reasons for dropouts from the study; (3) whether 
all participants met entry criteria; (4) whether continuation of the study is justified 
on the basis that additional data is needed to accomplish the stated aims of the 
study; and (5) conditions whereby the study might be terminated prematurely.
f)
Stopping Rules - This study will be stopped prior to its completion if: (1) the 
intervention is associated with adverse effects that call into question the safety of 
the intervention; (2) difficulty in study recruitment or retention will significantly 
impact the ability to evaluate the study endpoints; (3) any new information 
becomes available during the trial that necessitates stopping the trial; or (4) other 
situations occur that might warrant stopping the trial. Data on subject accrual and 
completion rates will be synthesized and evaluated annually to determine if the 
study should be terminated.  These data will be reviewed by the study PIs, with 
consultation from the study biostatistician.
Pennington Biomedical IRB FWA 00006218
 
Approved March 6, 2019