The Diet Composition and Energy Balance Pilot Study
Phase: NA
Conditions: Nutritional Physiological Phenomena, Obesity
Sponsor: Pennington Biomedical Research Center

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Protocol Ver.6 – 3/2/18
Protocol Title: The Diet composition and Energy Balance Pilot Study (The DEB Pilot Study)
PI: John W. Apolzan, PhD
Co-PI: Corby K. Martin, PhD
Sub-Investigators: 
Owen T. Carmichael, PhD
Nicole N. Fearnbach, PhD 
Kishore M. Gadde, MD
 
Background: 
Food form refers to the physical state of foods, i.e., if food is in beverage (liquid) or solid 
form. Adults do not fully compensate for calories consumed in beverages over the short-term in 
preload studies; therefore, it is thought that food form can affect energy intake and body 
weight1,2. A meta-analysis of pre-load studies by Almron-Roig suggested that food form affects 
energy intake3. However, previously it has been shown that energy compensation typically takes 
2-6 days in humans; thus, the validity of preload studies has been questioned4,5. Over four weeks, 
there is a weight gain with carbohydrate beverage intake but no difference between carbohydrate 
beverage and solid food form treatments2. In another four-week study, participants who 
consumed sugar-sweetened beverages (SSBs) gained far less weight than expected should no 
compensation have occurred6 and in a commentary on the article it was noted that further 
research is needed to determine if people compensate differently over the long-term to energy 
consumed in solid vs. liquid form7. Similarly, others have called for additional research on the 
extent to which compensation occurs over the long-term in response to energy from SSBs8. 
The effect of sugar intake on body weight over the long-term is not well understood when a 
liquid SSB and an SSB consumed in solid form are provided that are similar in macro- and 
micronutrients. Thus, the purpose of the current study is to test if weight change is differentially 
affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food 
form over 1 month. There will be no instructions provided for any other dietary modifications.
The provided foods that will be consumed by participants daily for 1 month in this study are: 
1) 1 20 oz. carbonated sugar sweetened beverage (SSB; 240 kcals). Added ingredients include: 
~2.1g whey protein powder.
Or 
2) 1 solid food that is made with the SSB syrup concentrate and is equivalent to one 20 oz. soft 
drink (solid; 240 kcals). Added ingredients: ~30 g water, ~3.0 g gelatin, ~3.5 mg sodium 
(added using NaCl), ~11.1 mg potassium (added using KCl) and ~11.5 mg calcium (added 
using CaCl).
Specific Aims: 
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Aim 1. Test the feasibility of having participants consume liquid and solid foods for 1 month and 
demonstrate our ability to acquire and analyze fMRI brain activation pre and post dietary 
intervention with a visual reward paradigm. 
Aim 2. Test for change in body weight. 
Hypothesis: The SSB group will have no difference in change in body weight compared 
to the solid group (between group effects). The SSB and solid groups will have increased weight 
compared to baseline (within group effects).  
Changes in brain activation will be measured and tested for differences among the 
groups. It is hypothesized that change in brain activity will not differ between the SSB and solid 
groups. But, it is hypothesized that both the SSB and solid group will experience change in 
activation in reward-related areas of the brain compared to baseline. 
The foods listed above will be provided to participants with instructions to consume one 
serving per day. The energy content of food provision in the SSB and solid groups will be 240 
kcal/day (SSB and solid groups will be isocaloric). Participants will receive no instructions for 
other dietary modifications; i.e., they will not be told to modify what or how much other food 
they consume. 
Inclusion and Exclusion Criteria: 
The target study group will be 20 men and women aged 21 to 65 years. 10 participants 
will be randomized to the SSB and solid groups, respectively. The participant population will 
include normal weight, overweight and obese (BMI 20.0 to 40.0 kg/m2) individuals. All 
inclusion/exclusion criteria will be based upon self-reported medical history/checklist. 
Participants must be able to consume study foods and be willing to archive their brain scans and 
eye tracking data. Participants who consume SSBs will be asked to maintain their regular SSB 
consumption in addition to the SSB (or solid food) associated with their random assignment). 
Participants will be stratified based on sex and BMI class. 
Exclusion Criteria:
Health Conditions:
•
Diabetes (Type 1 or 2)
•
Prediabetes 
•
Active cancer
•
Serious digestive disorders 
•
Other conditions that affect metabolism or body weight 
•
Uncontrolled Thyroid disorder (controlled = 6 months of medication)
•
Unable to consume study foods
•
Non- weight stable (more than 10 lbs. weight gain or loss in last 6 months)
•
Pregnancy 
•
Intentions of becoming pregnant in the next 2 months
•
Women who have undergone partial hysterectomy with intact ovary function
•
Any uncorrected vision problems
•
Color-blindness 
•
Left-handed 
•
Current or past alcohol or drug abuse problem 
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•
Have internal metal medical devices including cardiac pacemakers, aortic or 
cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, 
wire sutures, joint replacements, bone or joint pins/rods/screws/clips, metal plates, 
metal fragments in your eye, or non-removable metal jewelry such as rings.
•
Other contraindications to magnetic resonance scanning 
•
Unable or unwilling to complete the imaging procedures for the duration of the 
MRI scan due to claustrophobia or other reason.
•
      Allergy or intolerance to study product ingredients.
•
Any other medical, psychiatric or behavioral factors that in the judgment of the 
Principle Investigator that may interfere with study participation or the ability to 
follow the protocol
Medications/Non-Drug Therapies (within ~4 weeks prior to Screening):
•
Weight loss medications, diet pills
•
Non-topical steroids
•
Other medications that may affect fluid balance or weight
Lifestyle:
•
Consume more than seven 12 oz. sugar-sweetened beverages per week (~ 1, 12 
oz. SSB/day; diet soft drinks are ok)
•
Consume > 3 drinks/day of any alcoholic beverage
•
Smoker. (Former smokers must be smoke free for 6 months)
•
You plan to move out of the study area within the next 3 months, or plan to be out 
of the study area for more than 1 week (~7 days) during the course of the study.
Number of Subjects
We will enroll 20 right handed men and women aged 21-65 y with a BMI of 20.0-40.0 kg/m2. 
Recruitment Methods
Traditional PBRC recruiting methods will be utilized by marketing and the recruiting core. 
The Advertising and Recruitment Cores are responsible for recruiting potential participants for 
clinical trials from a population that includes a wide range of people of various ages, ethnic 
backgrounds and with varying degrees of health. Pennington Biomedical has a team of full-time 
employees dedicated to the recruitment and initial screening of clinical trials. Potential subjects 
will be identified via a large database of previous study participants along with the use of web, 
print, and media advertising. The Recruitment and Advertising Cores create and implement 
individualized, trial-specific advertising and awareness campaigns, including mass media, 
traditional advertising, and novel methods including social media, digital and email marketing. 
All advertising and awareness are approved by our on-site IRB to ensure ethical and disclosure 
standards are met. The PBRC database will also be utilized to find potential subjects for this 
study.
Study Timelines
Participants will come in for a screening visit. Then approximately a week (~ 7 days) later, 
participants will come in their Week 0 (baseline) study visit and be provided with ~1 week (~7 
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days) of food provision. This visit will occur based on self-reported luteal phase of menstrual 
cycle in women. Next, at approximately 1 week (~day 7), participants will return to the center for 
an adherence visit and further provision of study foods (Week 1). At approximately 2 weeks 
(~day 14), participants will return to the center for an adherence visit and further provision of 
study foods (Week 2). At approximately 3 weeks (~day 21), participants will return to the center 
for an adherence visit and further provision of study foods (Week 3). Finally, participants will 
come for their Week 4 assessment and adherence visit. Thus, participation will last 
approximately 5-6 weeks in total.  
Study Endpoints
Study Design: A randomized parallel arm design trial examining solid sugar vs. SSB treatments 
will be performed. The primary study endpoints are feasibility and change in body weight. 
Procedures Involved
Overview: 
Participants will arrive at the center following a minimum 10 hour fast. They will undergo 
anthropometric measurements, psychological and behavioral questionnaires, and fMRI.  
Table 1. Schedule of Procedures
Intervention Period
Visit Assessments
Screening 
Visit
Week 
0
Week 
1
Week 
2
Week 
3
Week 
4
Informed Consent
X
 
 
 
Anthropometrics (height, body weight) 
X
 
 
 
Anthropometrics (body weight, waist 
and hip circumference, and 
bioelectrical impedance) 
 
X
 
X
Brief Lifestyle Interview and non-
quantified food record 
X
 
 
 
Contact and Demographic Information
X
 
 
 
Food Taste Test
X
 
 
 
Food Craving Inventory (FCI), Yale 
Food Addiction Survey (YFAS) , 
Liking and Wanting Procedure, 
Retrospective Visual Analogue Scales 
(RVAS) , Barratt Impulsiveness Scale, 
Delayed Discounting Task, and Food 
Familiarity and Liking Procedure
 
X
 
X
Urine Pregnancy Test
 
X
 
X
fMRI (fasting and fed state)
 
X
 
X
Randomization
 
X
 
 
Study Product Dispensed
 
X
X
X
X
Adherence check/calculations (self-
report and container return), provision 
of study foods
 
 
X
X
X
X
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Dose: The energy content of food provision in the SSB and solid groups will be 240 kcal/day. 
Participants are to consume 1 unit per day of the study. 
Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not 
be told to modify what or how much other food they consume.
Food Acceptability Form: Participants will be asked to rate the study foods for appearance, odor, 
flavor, texture, sweetness, and overall acceptability at screening.  Each participant will be asked 
to circle the number from 1-9 for each of the characteristics after consuming the study foods.   
Psychological Assessments:
Food Craving Inventory (FCI). The FCI9,10 is a 28-item measure of specific food craving.  The 
FCI assesses the frequency with which an individual experiences a craving for a particular food.  
The measure consists of 4 empirically-derived factors:  High fats, Sweets, 
Carbohydrates/starches, and Fast food fats.  All items are scored in a 1 (Never) to 5 (Always) 
multiple choice format.  The measure has been shown to be reliable and support has been found 
all aspects of validity.
Yale Food Addiction Scale (YFAS). The YFAS11 is a 27-item self-report questionnaire used to 
identify individuals showing tendencies for addictive-like behaviors towards certain types of 
foods, such as those high in fat or sugar. The majority of the items are rated on a 5 point Likert 
scale, with responses ranging from “Never” to “Four or more times per week or daily” or a two 
point Likert scale consisting of “yes” or “no” responses. The measure also allows subjects to 
subjectively identify specific problem foods. Validity for the YFAS has been established.
Liking and Wanting Procedure. The liking and wanting procedure assesses explicit liking and 
wanting, followed by implicit wanting for the same target food stimuli12,13. The explicit task 
quantifies hedonic response, measured with visual analogue scales (VAS), to 16 food stimuli 
used in the implicit wanting task. A forced choice method is used to measure implicit wanting by 
presenting paired food stimuli from four food categories and asking participants to select the 
food they “most want to eat now”. Frequency of selections for each food category quantifies 
relative preference and reaction time measures implicit behavior change.  
Retrospective Visual Analogue Scale (RVAS). RVAS will be used to measure average ratings 
of appetitive sensations that participants experienced over the past week. This method of 
collecting VAS data has been found to be consistent with daily assessments of satiety14, and has 
been found to be reliable and valid measure of subjective states of appetite related to energy 
intake15.
Barratt Impulsiveness Scale (BIS). It is a 30 item scale that yields six first order factors 
(attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability 
impulsiveness) and three second order factors (attentional, motor, and non-planning 
impulsiveness).  It is a self-report measure of impulsive personality traits. 
Delay Discounting Task. Immediate rewards are preferred to delayed rewards of higher value 
and the amount of this “delayed discounting” provides an index of impulsivity. Weight loss 
outcomes could be influenced by discounting the long-term rewards of weight loss in relation to 
immediately available food rewards 16. Images of a preferred food will be presented and 
participants will be asked “Would you rather eat this food now or receive $10 tomorrow?” 
(Participants select the “food” or “money” responses). Reaction time will be recorded and the 
food image will be used with different monetary choices ($1, $5, $10, $20, $50, $100) with delay 
times of now, 4 hours, tomorrow, 1 week, 2 weeks, and 1 month.
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Food Familiarity and Liking Procedure. The Food Familiarity and Liking Procedure asks 
participants to evaluate a total of 105 images of food and control photos shown in the fMRI 
scanner paradigm following completion of all scanning procedures. Participants will see each 
photo and be asked whether they know what the food or item is and rate how much they like the 
food or item on a visual analog scale.
Here is the schedule for the screening and clinic visits:
Screening Visit: About 1.5 hours –Fasting (nothing to eat or drink other than water for at 
least 10 hours prior to visit) 
This visit will take place in the Outpatient Clinic Department of Pennington Biomedical.  The 
testing this day includes the following procedures:

Informed Consent

Current medication and supplement use

Demographic and Lifestyle Questionnaire (including contact information)

Lifestyle Interview
o
To discuss your understanding of the study and for the study staff to know what 
kinds of barriers may make it difficult for you to participate in the study. Such 
lifestyle barriers include your work or school schedule, outside activities, and 
other responsibilities may prohibit your from enrolling. 

Height

Weight

Food Taste Test 
Week 0: About 4 hours – Fasting (nothing to eat or drink other than water for at least 10 
hours prior to visit) after at least 7 hours of rest the previous evening
This visit will take place in the Outpatient Clinic Department of Pennington Biomedical.  The 
testing this day includes the following procedures:

Anthropometric Measurements – (body weight, waist and hip circumference, and 
bioelectrical impedance) 

Psychological and Behavioral Questionnaires

Females of child-bearing potential will have a urine pregnancy test 

MRI/fMRI – fasting and fed state 

Treatment consumption – fed state fMRI

1 week supply of study product dispensed
Week 1: About 30 minutes – Non-Fasting

Adherence check

1 week supply of study product dispensed
Week 2: About 30 minutes – Non-Fasting
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
Adherence check

1 week supply of study product dispensed
Week 3: About 30 minutes – Non-Fasting

Adherence check

1 week supply of study product dispensed
Week 4: About 4 hours – Fasting (nothing to eat or drink other than water for at least 10 
hours prior to visit) after at least 7 hours of rest the previous evening 
This visit will take place in the Outpatient Clinic Department of Pennington Biomedical.  The 
testing this day includes the following procedures:

Anthropometric Measurements – (body weight, waist and hip circumference, and 
bioelectrical impedance) 

Psychological and Behavioral Questionnaires 

Females of child-bearing potential will have a urine pregnancy test

MRI/fMRI – fasting and fed state 

Treatment consumption – fed state fMRI

Adherence check 
All participants need to come in within ± 2 days of their scheduled visit date. 
Phone calls, text messages and email are also permissible by the adherence coach as 
adherence checks during the dietary intervention. Also adherence coaches can request remote 
motoring i.e. pictures of study foods.  
Study Procedures:
As previously stated, the foods listed above will be provided to participants with 
instructions to consume one serving per day. If they happen to skip a day, participants will be 
instructed to consume the treatment on the following day on top of their normal daily provision. 
The energy content of food provision in the SSB and solid groups will be 240 kcal/day (SSB and 
solid groups will be isocaloric). Participants will receive no instructions for other dietary 
modifications; i.e., they will not be told to modify what or how much other food they consume. 
fMRI: Reward Activation
At baseline and follow-up, subjects will arrive to PBRC after an overnight fast where they will 
participate in a fMRI scanning protocol to assess brain response patterns to reaction times and 
attentional processing to food and control images.  The scanning session will begin with a 
structural scan where the participant will be asked to lie as still as possible while we scan their 
brain.  The paradigm will immediately follow in which subjects will view images of pictures 
with up to seven categories: 1) High Sugar/High Fat (HS/HF), 2) High Complex 
Carbohydrate/High Fat (HCC/HF), 3) Low Carbohydrate/High Protein/High Fat (LC/HP/HF), 4) 
High Sugar/Low Fat (HS/LF), 5) High Complex Carbohydrate/Low Fat (HCC/LF), 6) Low 
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Carbohydrate/High Protein/ Low Fat (LC/HP/LF), and/or 7) Control Images presented in an 
event design.  Subjects will also be asked to solve a mental task which may include clicking 
buttons to rate pictures. Additionally, we may collect eye tracking data during the fMRI scanning 
protocol to further assess attentional processing of food-related visual cues.  
Fasting vs. Fed Neural Activation Patterns:
Subjects will complete all scanning procedures in a fasting state and additionally post 
meal consumption.  After completing the fMRI scan in the fasted state, subjects will participate 
in a meal challenge by consuming their dietary treatment and after will undergo the same fMRI 
image protocol as before to assess changes in activation in response to fasted and fed conditions.  
Recently Smeets et al. investigated how neural activation patterns in response to caloric and non-
caloric stimuli are modulated by hunger (fasted) and satiety (fed).  They showed a significant 
interaction between hunger and energy content in the solutions and that tasting energy during 
satiety resulted in greater activation patterns than during hunger17.  For these reasons, we will 
assess reward activation patterns in response to food cues in the fasted and fed state.
MR scan preparation
At the phone screen, each participant will be asked a series of questions regarding possible 
contraindications to MR scanning. Study personnel will ask additional questions and clarify any 
uncertainties with the participant on possible contraindications to MR scanning at the baseline 
visit.  On the day of MR scanning, the MR technician will rescreen the participant out of caution.  
Participants scheduled for a functional MRI scan that involves viewing images, listening to 
sounds, and/or pressing buttons to respond to questions may be asked to do a practice session in 
front of a computer (outside the scanner) on the day of the scan.  During the practice session, the 
participant will view similar images, hear similar sounds, and press computer keys in similar 
ways to familiarize them to what will happen inside the scanner. The MR technician will then 
ensure that all metallic items are removed from the exterior of the body of the participant, and 
that clothing that might cause image artifacts are removed.  For brain scans, some participants 
wearing simple cotton clothing are expected to be able to remain clothed.  The MR technician 
will provide the participant with earplugs to reduce scanner noise.  The MR technician will then 
place the participant on the MR table, supplying cushioning under the neck and legs as needed to 
ensure participant comfort.  A blanket will be provided to participants that feel cold on the MR 
table.  The MR coil will then be placed over the head and the participant is then inserted into the 
MRI tube by the MR technician.
Physiological monitoring and stimulus devices
Physiological monitoring will be applied to the participant.  The reason for physiological 
monitoring is that it provides ancillary data that improves the quality of the collected MRI data. 
Physiological stimulation devices will be applied to measure the response of the brain to stimuli, 
which is of scientific interest.  The devices are listed below.
Respiratory monitor: The respiratory monitor is a belt that fits around the chest at the level of 
the diaphragm of the participant.  The MRI machine records the rise and fall of the diaphragm 
during scan acquisition.  Dynamic MRI data, especially functional MRI and perfusion MRI of 
the brain, is commonly corrected post hoc by regressing this respiratory signal from the collected 
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time series data.  The belt is made of comfortable material and stretches amply so it does not 
restrict the ability to breathe normally.
Pulse oximeter: The pulse oximeter is an optical sensor that clips onto one of the fingers of 
either hand or toes of either foot.  It shines a light through the skin to gather proxy measures of 
blood oxygenation while the scan is being collected.  Dynamic MRI data, especially functional 
and perfusion MRI, is commonly corrected by regressing the time course of peripheral blood 
oxygenation out of the raw time series data acquired.  The sensor attaches snugly to the finger 
but generally does not pinch or cut off the flow of blood.
Image and video display screen: Participants view images projected from a screen through a 
mirror mounted on the MRI head coil.  Commonly deployed experimental paradigms display 
images during fMRI data collection to assess responses of the brain to various visual stimuli.
Headphones: MR-safe headphones are worn inside the head coil and over the ears. 
Button boxes: In functional MRI experiments, participants are commonly asked to indicate 
responses to questions about the images, sounds, smells, and tastes exposed to them in the 
scanner by pressing buttons on button boxes placed in their hands.  
MR scanning 
The scanner technician runs a series of sequence acquisitions, each of which quantify a different 
aspect of tissue structure and function, or covers a slightly different portion of the anatomy.  
Each sequence acquisition emits a series of buzzing or grinding noises over the course of 1 to 10 
minutes while data is acquired.  Before each sequence acquisition, the technician communicates 
with the participant via a speaker and microphone inside the scanner bore; the participant is 
asked about his/her comfort and is reminded to lie perfectly still during the subsequent sequence 
acquisition.  The technician has an unobstructed view of the participant to identify movement 
during acquisition or other signs of discomfort.  After scanning, the participant is removed from 
the scanner tube and assisted out of the scanner suite.
Statistical analysis. The study will use an intent to treat approach. Following evaluation of data 
normality, a mixed model ANOVA will be used to test if change on the outcome variables 
differed between treatment and control across time. LS Means will also test if change from 
baseline was significantly different from 0. Fixed effects will include age and sex. 
Power Analysis: 
Since this is a pilot and feasibility study, power calculations have not been performed. This study 
will allow us to obtain crucial feasibility data as well as data to perform future power 
calculations for a larger grant.  
Data Banking
The PIs and co-investigators will have access to the data for future analysis and they may 
be shared with outside investigators.  
Data Management
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The data management will be conducted by the Pennington Biomedical Research Computing 
Group.  There will be limited access to all data including locked cabinets for paper files and 
password protected computers for electronic data.  Identifiers will be kept separate from the data.  
Provisions to Monitor the Data to Ensure the Safety of Subjects
The Principal Investigators (PIs) are responsible for monitoring the data, assuring protocol 
compliance and conducting safety reviews at the specified frequency [quarterly]. During the 
review process, the Principal Investigators will evaluate whether the study should continue 
unchanged, requires modification/amendment or should close to enrollment. 
The Principal Investigators or the Institutional Review Board (IRB) or have the authority to stop 
or suspend the study or require modifications. 
This protocol presents minimal risks to subjects, and adverse events or other problems are not 
anticipated. In the unlikely event that such events occur, the PIs are responsible for reporting to 
the IRB and any appropriate funding and regulatory agencies any serious, unanticipated and 
related adverse events or unanticipated problems involving risks to subjects or others. The 
investigators will apprise fellow investigators and study personnel of all adverse events that 
occur during the conduct of this research project. The investigator will meet this obligation 
through email as they are reviewed by the Principal Investigators. The study’s Research 
Monitor(s) and decision-making bodies will be informed of serious adverse events within 10 
working days of the event becoming known to the Principal Investigators. If there are 
unanticipated problems involving risks to subjects or others, these should be reported to the IRB 
per HRPP Policy 8.0.
The sub-investigator, Kishore M. Gadde, MD, will review adverse events. 
Withdrawal of Subjects
Subjects may be withdrawn from the study if he/she misses study visits or food provision 
and will be notified of their withdrawal via telephone or mail.
If a subject voluntarily withdraws from the study, no additional data will be collected and 
they will be considered drop outs in the study. 
Risks to Subjects
This study does not involve major risk to study participants.  

Fasting for 10 hours: There is a possibility that fasting for 10 hours may make you feel 
nauseous.  

Self-reported Questionnaires: There are no anticipated risks from completing self-
report questionnaires.  Due to the sensitive nature of the questionnaires, you may skip any 
questions that you do not wish to answer.   

Bioelectrical Impedance Analysis (BIA) Measurement: You will be asked to change 
into a gown and to remove all footwear and socks/stockings.  Once changed and barefoot, 
you will be asked to stand on a scale (similar to a large gym scale), and you may be asked 
to hold on to hand electrodes on each side of the scale.  You will be asked to step off of 
the scale once the measurement is complete (less than one minute).  
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o
There is no risk associated with the BIA measurement.  However, subjects with 
medical implants such as a pacemaker or metal joint replacements cannot be 
measured on the machine.  

Weight Gain: There is a possible chance that the Calories will slightly increase body 
weight. 

Brain MRI: This scan is performed to measure the size of your brain and lasts 
approximately ten minutes.  You will change into a hospital gown and remove all objects 
containing metal from your body. During the scan, you will lie on your back on the 
scanner table with your head in a cradle.  The scanner table will then move you into the 
magnet. During the scan, you will hear loud tapping noises.  You will be given head 
phones for protection from the scanner noise and can listen to music during the scan if 
desired.  You will also be given a call button should you need the MRI tech during the 
exam.  This scan is for research purposes only and not for diagnostic treatment.
o
 MRI Risks:   
There are no known biological risks associated with magnetic resonance scanning.  It has 
been used routinely for over 20 years.  It produces side effects in very few situations.  Those 
situations include:

Metal: Because the magnetic resonance machine uses a magnetic field, it can move 
any metallic objects that are inside the body.  This disruption of metal inside the 
body is extremely dangerous to you and may even be life threatening.  If you think 
you may have a cardiac stent, metallic implant, metallic piercings, shrapnel, or any 
other metallic material in your body, it is of utmost importance that you alert the 
study coordinator or MR technician. If you have metallic materials in your body that 
cannot be removed, we will exclude you from this study for your safety.  

Electronics: Magnetic resonance imaging involves the use of radio frequency energy 
that can disrupt the functioning of electronic devices.  If you think you might possess 
a pacemaker or any other electronic medical device inside your body, it is of utmost 
importance that you inform the study coordinator or MR technician.  If you have any 
such electronic devices we will exclude you from this study for your safety.

Tattoos and cosmetics: Some tattoos and cosmetics contain metallic materials that 
can heat up during scanning, especially if they are located on the part of the body 
being scanned.  If the metallic material heats up enough, you may feel an 
uncomfortable burning sensation, and a skin burn may develop.  If you have any 
tattoos or cosmetics that might contain metallic materials, please alert the study 
coordinator or MR technician.  If you feel a burning sensation on your skin, alert the 
study coordinator or MR technician.  In some cases, the amount of metallic material 
in the area being scanned is so excessive that the scan must be stopped.  In other 
cases, a cold compress placed over the metallic material will be used to prevent the 
burning sensation.

Confinement: During the MR scan, you will be lying down on a table inside of a 
metal tube.  The metal tube is a confined place.  This might produce a feeling of 
claustrophobia, which can be distressing.  If you have experienced claustrophobia in 
the past, you might become too distressed to complete the scan.  If you become 
distressed during the scan due to confinement in the scanner tube, please alert the 
MR technician and the scan will be halted.
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
Noise: The MRI machine creates a loud, rhythmic noise that sounds like grinding or 
churning.  This can be distressing to those who are sensitive to loud noises.  You will 
be provided with earplugs to reduce the noise.  But if you find the machine noises 
distressing, alert the MR technician and the scan can be halted.

Peripheral nerve stimulation: During the MR scan, the magnetic field around your 
body goes through rapid changes.  These changes are all within safety limits set by 
the Food and Drug Administration.  But, some people experience twitching in the 
nerves of their arms or legs as a result of these magnetic field changes.  This 
twitching is generally not painful, and it stops at the end of the MR scan.  But the 
feeling of inadvertent muscle twitching may make you feel disoriented or 
uncomfortable.  If you experience this and wish to stop the scan as a result, please 
tell the MR technician.

Physical frailty: The MR technologist performing the scan has received extensive 
training in how to position all participants, including elderly ones, in the MRI 
machine safely and comfortably.  However, some older people have a more difficult 
time walking or moving their bodies due to arthritis and other conditions. There is a 
slight chance that these individuals could feel discomfort or fall during transitions 
into or out of the MRI scanner.  The technologist will ensure that the walkway to the 
scanner is safe for you to walk on, will place cushioning on the scanner table for your 
comfort, and will carefully guide your movements around the scanner to minimize 
this risk.

Venous thromboembolism: In some elderly or obese individuals, lying down 
perfectly still for multiple hours can slightly increase the risk that blood clots develop 
in the blood vessels.  These blood clots can be hazardous to your health.  The 
technologist will make every effort to keep your time in the MRI machine as short as 
possible to reduce this risk.  Also, you will have breaks during your time in the MRI 
machine, and during these breaks the technologist will ask you to move your arms 
and legs and reposition your body to get comfortable.  Moving around in this way 
reduces your risk of blood clots.
Incidental Findings
We will follow the recommendations of a Presidential panel in handling incidental findings on 
MRI.  First, we indicate to the participant whether or not there is a well-established set of 
incidental findings for the scan they are undertaking, and if so what those incidental findings are. 
For scans without a well-established set of incidental findings, we will provide a list of incidental 
findings that we feel may be possible.  We will then describe the difference between clinically 
actionable incidental findings and non-clinically-actionable incidental findings.  We will then ask 
the participant to decide whether they want to be informed of non-clinically-actionable incidental 
findings.  Participants will be informed that informing them of clinically-actionable incidental 
findings is required for participation in the study.  In the event that study personnel identify MR 
abnormalities, they will consult with a radiologist who will determine the clinical relevance of 
the abnormalities.  Participant identity will not be shared with the radiologist in this event.  If the 
radiologist determines that an MR abnormality is relevant to personal health, the radiologist will 
then determine whether the finding is clinically actionable.  In the event that the finding is 
clinically actionable, or if the participant consented to be informed of non-clinically actionable 
incidental findings, study personnel will inform the participant and will suggest discussing the 
findings with the personal health professional of the participant.  In the event of an incidental 
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finding that is to be released to the participant, the imaging findings flow from the study staff, to 
a radiologist, to the Investigator who explains the findings with the participant.  
Potential Benefits to Subjects
There are no direct benefits for subjects for participation in the study.  The MR scan 
data collected for the study is not designed to be used by a doctor to evaluate physical 
health the way a scan done in a hospital or clinic is.  That means that any abnormalities in 
the body that are relevant to personal health will not necessarily be noticed by study 
personnel. However, MR scanning may result in discovery of an unexpected incidental 
finding as described above.  Therefore, there is a small chance that this study will provide 
benefit by revealing problems with personal health that would not have been discovered 
without MR scanning.
A participant might also benefit by learning new information about the structure and 
function of the brain.  Such information may be interesting to the participant.
Sharing of Results with Subjects
The participants may receive a structural image of their brain if an inquiry is made.
Setting
We will utilize the clinical facilities as well as the neuroimaging center at Pennington 
Biomedical Research Center to conduct this study. 
Compensation
Subjects will receive $75 for completing Week 0 baseline visit, $10 for completing 
Week 1 visit, $10 for completing Week 2 visit, $10 for completing Week 3 visit, and 
$125 for completing Week 4 visit, for a maximum of $230. 
Number of Subjects
We aim to complete the study on a total of 20 subjects.  
Provisions to Protect the Privacy Interests of Subjects
All attempts will be made to maintain a subject’s privacy.  Safeguards such as 
password protected computer and networks have been put in place in order to limit access 
to subject data.  
Subjects will be given ample time to read over the consent, ask questions, and agree 
to participate in the research study.  Subjects may decline answering questions they are 
not comfortable with.  Each procedure will be explained to the subject before it is 
performed. 
We will always ensure the privacy of the subjects.  
  
Compensation for Research-Related Injury
No compensation will be provided for research-related injury.
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Economic Burden to Subjects
All study-related tests and procedures will be at no cost to the subject.  The subject 
will incur transportation costs in getting to PBRC.
Consent Process
The P.I. or one of the designated clinic staff will obtain informed consent in the clinic 
during the first visit.  Ample opportunity will be given for the subject to review the consent and 
ask any questions prior to signing the consent form.  If subjects wish, they can take the form 
home and return at a different visit.  Also, as we are aware consent is an ongoing process.  
Data Sharing
The participant is asked to allow MRI scans to be stored and used for research at a later time.  
Participants that refuse to have scans kept for future research will be excluded from the study.  
The MRI scans will be stored indefinitely. The scans may be given to other investigators or MRI 
technology companies for future research as well. The future research may take place at 
Pennington Biomedical and may involve Pennington Biomedical Researchers in this study. The 
MRI scans may be shared with faculty at the LSU School of Kinesiology. The future research 
may not take place at Pennington Biomedical Research Center and may not be reviewed by 
Pennington Biomedical Research Center’s Institutional Review Board. For privacy and 
confidentiality, MRI scans will be labeled with a unique series of letters and numbers. 
Pennington Biomedical will store MRI scans with this unique identifier. The research done with 
MRI data may help to develop new products in the future, or may be used to establish a 
diagnostic test that could be patented or licensed. The participant will not receive any financial 
compensation for any patents, inventions or licenses developed from this research.
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References: 
1.
Mattes RD. Dietary compensation by humans for supplemental energy provided as ethanol or 
carbohydrate in fluids. Physiol Behav. 1996;59(1):179-187.
2.
DiMeglio DP, Mattes RD. Liquid versus solid carbohydrate: effects on food intake and body 
weight. Int J Obes Relat Metab Disord. 2000;24(6):794-800.
3.
Almiron-Roig E, Palla L, Guest K, Ricchiuti C, Vint N, Jebb SA, Drewnowski A. Factors that 
determine energy compensation: a systematic review of preload studies. Nutrition Reviews. 
2013;71(7):458-473.
4.
Bray GA, Flatt JP, Volaufova J, Delany JP, Champagne CM. Corrective responses in human food 
intake identified from an analysis of 7-d food-intake records. Am J Clin Nutr. 2008;88(6):1504-
1510.
5.
Saris WHM. Limits of human endurance: lessons from the Tour de France.  . In: Kinney JM, 
Tucker HN, eds. Physiology, stress, and malnutrition: functional correlates, nutritional 
intervention. . Philadelphia: Lippincott-Raven Publishers; 1997:451-462.
6.
Reid M, Hammersley R, Duffy M, Ballantyne C. Effects on obese women of the sugar sucrose 
added to the diet over 28 d: a quasi-randomised, single-blind, controlled trial. The British journal 
of nutrition. 2013:1-8.
7.
Allison DB. Liquid calories, energy compensation and weight: what we know and what we still 
need to learn. The British journal of nutrition. 2013:1-3.
8.
Kaiser KA, Shikany JM, Keating KD, Allison DB. Will reducing sugar-sweetened beverage 
consumption reduce obesity? Evidence supporting conjecture is strong, but evidence when 
testing effect is weak. Obes Rev. 2013;14(8):620-633.
9.
White MA, Grilo CM. Psychometric properties of the Food Craving Inventory among obese 
patients with binge eating disorder. Eat Behav. 2005;6(3):239-245.
10.
White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and 
validation of the food-craving inventory. Obes Res. 2002;10(2):107-114.
11.
Gearhardt AN, Corbin WR, Brownell KD. Preliminary validation of the Yale Food Addiction Scale. 
Appetite. 2009;52(2):430-436.
12.
Finlayson G, King N, Blundell J, E,. Liking vs. wanting food: Importance for human appetite 
control and weight regulation. Neuroscience & Biobehavioral Reviews. 2007;31(7):987-1002.
13.
Finlayson G, king N, Blundell J, E,. The role of implicit wanting in relation to explicit liking and 
wanting for food: Implications for appetite control. Appetite. 2008;50(1):120-127.
14.
Womble LG, Wadden TA, Chandler JM, Martin AR. Agreement between weekly vs. daily 
assessment of appetite. Appetite. 2003;40(2):131-135.
15.
Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue 
scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab 
Disord. 2000;24(1):38-48.
16.
Appelhans BM. Neurobehavioral Inhibition of Reward-driven Feeding: Implications for Dieting 
and Obesity. Obesity. 2009;17(4):640-647.
17.
van Rijn I, de Graaf C, Smeets PA. Tasting calories differentially affects brain activation during 
hunger and satiety. Behavioural brain research. 2015;279:139-147.
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