Modulating Dietary Protein to Alter Circulating and Gut Metabolites
Phase: NA
Conditions: Diet, Healthy
Sponsor: Stony Brook University

 
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PROTOCOL TITLE: 
Response: Modulating dietary protein to alter circulating and gut metabolites 
 
 
PROTOCOL VERSION/AMENDMENT # AND DATE 
Response: IRB2019-00415_MOD006; 1/23/20 
 
PRINCIPAL INVESTIGATOR: 
Response: David C. Montrose, Ph.D. 
 
DATE: 
Response:  
 
1.0 Objectives 
 
1.1 
Describe the purpose, specific aims, or objectives of this research. Specifically, 
explain why it is important to do the study. 
Response: This study will test whether altering protein content in diet will change the levels of 
small molecules in blood and feces, with a major focus on amino acids. Additionally, we will test 
whether these dietary alterations affect gut bacteria. Many of the nutrients that individuals take in 
through diet can impact human health. More specifically, our group and others have shown that 
dietary amino acids enhance tumor growth through their use of these small molecules as a fuel 
source. We believe that reducing overall protein consumption will benefit cancer patients by 
reducing the amount of amino acids that tumors can use to support their growth. Before testing 
this, a study in healthy volunteers needs to be carried out to determine whether altering the 
amount of protein in their diet, impacts the levels of amino acids (and related metabolites) in 
blood or feces. By demonstrating that we can alter these small molecules in healthy individuals, 
it will provide us with information on the dietary formulation and duration of consumption 
required to achieve the biological effect we are seeking in future studies with cancer patients. To 
this end, we plan to carry out a study to determine whether modulating the amount of protein in 
specially formulated diets alters small molecules (e.g. amino acids) found in the blood and feces, 
as well as the types of bacteria found in feces, in healthy volunteers. Positive data from this study 
will provide the rationale for testing whether modulating dietary protein in cancer patients is 
beneficial. 
 
 
 
1.2  
State the hypothesis to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 

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Response: We hypothesize that modulating dietary protein content will alter blood and fecal 
metabolites and cause a shift in the types of bacteria found in the gut.  
 
 
2.0 Scientific/Safety Endpoints 
 
2.1 
Describe the scientific endpoint(s), the main result or occurrence under study.   
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response:  
To determine whether reducing protein intake alters: 
Circulating metabolites as determined by targeted metabolite profiling of blood. 
Fecal metabolome as determined by targeted metabolite profiling. 
Fecal microbiota as determined by 16S rRNA and metatranscriptomic analyses. 
 
 
 
3.0 Background 
 
3.1  
Provide the scientific or scholarly background, rationale, and significance of the 
research based on the existing literature and how it will contribute/fill in gaps to existing 
knowledge.  
Response: It is known that tumors have an affinity for taking up amino acids from circulation or 
nearby tissues to use as a fuel source, to enhance their growth. Work in rodents by our group 
and others, has shown that when the levels of amino acids are reduced in diet, tumor growth is 
slowed and tumors are more susceptible to anti-cancer therapies. There are currently limited 
dietary recommendations for cancer patients, which represents an urgent and unmet need. It is 
likely that reducing dietary protein will be beneficial, however this has not been tested. In 
advance of carrying out a study in cancer patients a study in healthy volunteers needs to be 
carried out to determine whether altering the amount of dietary protein impacts the levels of 
amino acids (or other metabolites) in blood or the intestine. By demonstrating that we can 
induce alterations in healthy individuals, it will provide us with the information on the dietary 
formulation and duration of consumption required to achieve the biological effect we are seeking 
in cancer patients, for future studies. 
 
 
3.2  
Include complete citations or references:  

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Response: Maddocks et al., Nature, 2012 
                  Labuschagne et al., Cell Reports, 2014 
                  Maddocks et al., Nature, 2017 
                  Montrose et al., unpublished 
 
 
4.0 Study Design 
 
4.1  
Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, and observational). Indicate if 
there is randomization, blinding, control group, etc. If randomizing, explain how this will 
be achieved. 
Response: The proposed study is experimental. Individuals will be provided a 'baseline' diet for 
1 week then switched to a high protein diet for 2 weeks then to a low protein diet for 2 weeks. An 
additional 2 days will be allotted at the end of each feeding period to allow for sufficient time to 
collect samples) potentially adding an additional week to the entire study (See Figure 1 below). 
If subjects are able to provide samples immediately after completing a given feeding period, they 
will immediately be advanced to the next stage of the study. Therefore, the study will last from 5 
to 6 weeks depending on the efficiency of sample collections. Samples will be collected after the 
acclimation period and after completion of the high protein diet period and after completion of 
the low protein period (see Figure 1 below). Therefore, individuals will serve as their own 
controls.  
 
 
5.0 Local Number of Subjects 
 
5.1 
Indicate the total number of subjects who will be enrolled or records that will be 
reviewed through Stony Brook. 
Response: We will enroll 14 subjects with the prediction that 10 will complete the study. Given 
that the subjects are healthy volunteers, medical records will not be searched but instead 
subjects' health status will be evaluated through a brief health questionnaire (provided as an 
attachment to this protocol application).  
 
5.2 
If this study is only being conducted through Stony Brook, provide statistical 
justification (i.e. power analysis) for the number of subjects provided in 5.1 above.  If 
qualitative research, so state, and provide general justification for the total number of 
subjects proposed. 
 
Response: The statistical analysis for the primary aim of the study will compare circulating 
amino acid levels in subjects after consuming high or low protein diets for 2 weeks. We will 

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enroll 14 subjects with the prediction that 10 will complete the study. A sample size of 10 
subjects will allow 80% power to detect minimum differences of 0.996 standard deviations in 
plasma amino acid levels at 5% significance with the use of paired t-tests.  
 
 
5.3 
If applicable, indicate your screen failure rate, i.e., how many subjects you expect 
to screen to reach your target sample.   
Response: We will have 2 layers of screening during recruitment. The initial screening will be 
Qualtrics-based and done remotely upon a potential subject viewing an advertisement and 
accessed from a QR code on the paper announcements or as a link in the email announcements. 
This initial screen will exclude potential participants if they don't meet the basic eligibility 
criteria (screening survey attached to this protocol). This will be done anonymously if they don't 
pass the survey. We predict that about 40 people will take the screening survey and 50% of the 
individuals who take this initial survey will not be eligible. The second screen will occur in 
person and consist of individuals completing a health questionnaire and being provided a 
detailed description of study design and requirements to participate in the study. The detailed 
description will include a review of the two choices of menus/ingredients for each phase of the 
study, followed by written agreement by the subject to eat the foods provided.  Of the 20 people 
remaining who will undergo the in-person screening, we predict that approximately 20% of those 
individuals will be excluded, resulting in our goal of enrolling 14 people to result in 10 people 
having completed the entire study.  
5.4 
Justify the feasibility of recruiting the proposed number of eligible subjects within 
the anticipated recruitment period. For example, how many potential subjects do you 
have access to? What percentage of those potential subjects do you need to recruit? 
Response: In light of the fact that we will be targeting SBU students for recruitment, 
there is a pool of approximately 25,000 individuals. Therefore we believe that reaching 
our goal of enrolling 14 will be feasible.  
 
6.0 Inclusion and Exclusion Criteria 
NOTE:  If your study is more than minimal risk, you must also upload a copy of your 
inclusion/exclusion checklist (with space for specific subject values) to be completed at 
time of enrollment of each subject. 
 
6.1 
Describe, in bullet points, the criteria that define who will be included in this 
study: 
Response: *Age of 18-30 years 
                 *BMI of 18-29.9 
                 *Pregnancy 
 

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6.2 
Describe, in bullet points, the criteria that define who will be excluded from this 
study: 
Response: *Those with a history of significant illness including diabetes, renal, 
                   liver or cardiovascular disease, malnutrition, GI disease (including  
                   IBS, IBD, chronic constipation or diarrhea), mental illness (i.e. 
                  depression, bipolar disorder) 
                 *Those adhering to a vegetarian or vegan diet. 
                 *Those having taken antibiotics within 1 month of starting the study 
 
 
6.3 
Describe how individuals will be screened for eligibility.  Upload all relevant 
screening documents with your submission (screening protocol, script, questionnaire). 
Identify who will certify that subjects meet eligibility requirements.  
Response: We will have 2 layers of screening during recruitment. The initial 
screening which will be Qualtrics-based and done remotely (accessed from a QR 
code on the paper announcements or as a link in the email announcements) and 
will immediately exclude potential participants if they don't meet the basic 
eligibility criteria (screening survey attached to this protocol). This will be done 
anonymously if they don't pass the survey. If they do pass the survey, individuals 
will submit their name, email address and phone number so that they can be 
scheduled for a follow up in-person screening. The second screen will occur in 
person. The in-person interview will be conducted by a dietetic intern from the 
Dietetic Internship of the Division of Nutrition at Stony Brook University in room 
206 of the Earth and Space Science (ESS) building at Stony Brook University 
(private office) or in room 3-064C in the HSC building on the East side of the 
Stony Brook University campus (conference room located in the office suite of the 
Division of Nutrition). During this interview, interested participants will be 
provided greater detail of the study design (i.e. told that they must only consume 
the meals they are provided and must pick up their daily meals each day for the 
period of the study) to determine whether they are still willing to participate after 
receiving this information. They will also be asked to complete a health 
questionnaire (health questionnaire attached to this protocol). Based on inclusion 
and exclusion criteria the dietetic intern will enroll subjects and obtain consent.  
Dietetic interns will then teach the subjects how to complete the Qualtrics-based 
food log and conduct the indirect calorimetry study.    
 
6.4 
Indicate whether you are specifically recruiting or targeting any of the following 
special populations in your study using the checkboxes below. (You will be asked for 
additional information in Section 7 if you check any of these boxes)  
Response:  N/A 
 

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☐ 
Adults unable to consent 
☐ 
Minors (under 18 years old) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
6.5 
Indicate if you will include minorities (American Indians, Alaskan Native, Asian, 
Native Hawaiian, Pacific Islander, Black [not of Hispanic origin] and Hispanic) as 
Federal mandates require that you include minorities unless you can justify their 
exclusion 
Response:  
 
 
☒ 
Yes 
 
☐ 
No, Justify: 
 
6.6 
Indicate whether you will include non-English speaking individuals in your study.  
Provide justification if you will specifically exclude non-English speaking individuals. 
Review http://research.stonybrook.edu/human-subjects-standard-operating-
procedures/policy-non-english-speakers-research-subjects for SBU policy on inclusion of 
non-English speakers. Upload any translated materials (consent, questionnaires, etc).  
Response: Since our subject population will be undergraduate, graduate or medical/dental 
students, therefore all participants will have a working knowledge of English.  
 
 
7.0 Vulnerable Populations 
 
7.1 
For research that involves pregnant women, review, complete and upload 
Supplemental Form A:  Pregnant Women, Fetuses, Non-Viable Neonates , or Neonates of 
Uncertain Viability. 
☐ 
Confirmed 
☒ 
N/A:  This research does not involve pregnant women. 
 
7.2 For research that involves neonates of uncertain viability or non-viable neonates, 
review, complete and upload Supplemental Form A:  Pregnant Women, Fetuses, Non-
Viable Neonates, or Neonates of Uncertain Viability. 
☐ 
Confirmed 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of uncertain 
viability. 
 

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7.3 
For research that involves prisoners, review, complete and upload Supplemental 
Form H: Prisoners  
☐ 
Confirmed 
☒ 
N/A:  This research does not involve prisoners. 
 
7.4 
For research that involves minors (under 18 years), review, complete and upload  
Supplemental Form F: Minors 
☐ 
Confirmed 
☒ 
N/A:  This research does not involve persons who have not attained the legal age for 
consent to treatments or procedures (“children”). 
 
7.5 
For research that involves adults who cannot consent for themselves,  you will be 
asked additional information in Section 25 (“Informed Consent”) 
☐ 
Confirmed 
☒ 
N/A:  This research does not involve this population  
 
7.6 
Consider if other specifically targeted populations such as students, employees of 
a specific firm, or educationally or economically disadvantaged persons are vulnerable.  
Provide information regarding their safeguards and protections, including safeguards to 
eliminate coercion or undue influence. 
Safeguards include: 
 
☒ 
N/A 
 
8.0 Eligibility Screening  
 
8.1 
Describe screening procedures for determining subjects’ eligibility.  Screening 
refers to determining if prospective participants meet inclusion and exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaires) as attachments.  
Response: We will have 2 layers of screening during recruitment. The initial 
screening which will be Qualtrics-based and done remotely (accessed from a QR 
code on the paper announcements or as a link in the email announcements) and 
will immediately exclude potential participants if they don't meet the basic 
eligibility criteria (screening survey attached to this protocol). This will be done 
anonymously if they don't pass the survey. If they do pass the survey, individuals 
will submit their name, email address and phone number so that they can be 
scheduled for a follow up in-person screening. The second screen will occur in 
person. The in-person interview will be conducted by a dietetic intern from the 
Dietetic Internship of the Division of Nutrition at Stony Brook University in room 

PROTOCOL TITLE: 
 
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206 of the Earth and Space Science (ESS) building at Stony Brook University 
(private office). During this interview, interested participants will be provided 
greater detail of the study design (i.e. told that they must only consume the meals 
they are provided and must pick up their daily meals each day for the period of 
the study) to determine whether they are still willing to participate after receiving 
this information.  They will also be asked to complete a health questionnaire 
(health questionnaire attached to this protocol). They will be asked if they are 
pregnant or are planning to become pregnant. Based on inclusion and exclusion 
criteria the dietetic intern will enroll subjects and obtain consent.   
 
 
☐ 
N/A:  There is no screening as part of this protocol. 
 
9.0 Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be recruited.  NOTE:  If you 
select this option, please make sure that all records review procedures and inclusion/exclusion 
screening are adequately described in other sections, including date range for records that will be 
reviewed. 
 
9.1 
Describe source of subjects: When, where, and how potential subjects will be 
recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study. These may include, but are not limited to: 
ResearchMatch.org, physician referral, Office of Clinical Trials database, West Campus 
departmental pools, reviewing medical charts, Research Participant Groups/help groups, 
advertising companies, call centers, in person announcements / presentations 
Response: The study will be advertised on the weekly 'Campus Announcements' email blast, 
emails sent via student group listservs (e.g. medical students and student clubs) posted in 
academic buildings, residence halls, cafeterias and locations of student activity. 
 
 
9.2 
Describe how you will protect the privacy interests of prospective subjects during 
the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself. This is 
NOT asking about confidentiality of data.   
Response: Recruitment flyers and email blasts will be distributed via public venues and inclusive 
list-serve groups. 
 
 
9.3 
Identify/describe any materials that will be used to screen/recruit subjects and 
upload copies of these documents with the application. They may include, but are not 

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limited to Telephone scripts for calling, flyers, Questionnaires, Posters,  Letters or 
written material to be sent or emailed, pamphlets, posted advertisements, email 
invitations.  
Response: The study will be advertised as text in the weekly email announcements (text 
attached) and as a paper flyer posted around campus (flyer attached). An initial screening 
questionnaire will be Qualtrics-based and completed remotely (accessed from a QR code on the 
paper announcements or as a link in the email announcements) and will immediately exclude 
potential participants if they don't meet the basic eligibility criteria (screening survey attached). 
A health questionnaire will be provided at the in-person interview to assess basic health status 
and medications (questionnaire attached).  
 
 
10.0 Research Procedures  
Provide a detailed description of all research procedures or activities being performed on the 
research subjects. This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  For 
studies that have multiple or complex visits or procedures, consider the addition of a schedule of 
events table in in your response. Be sure to include: 
• Procedures being performed to monitor subjects for safety or to minimize risks.  
• All drugs and devices used in the research and the purpose of their use, and their 
regulatory status 
Response: After providing consent, subjects will undergo an indirect calorimetry test, which 
involves breathing through a disposable, single-use mouth piece into a machine that estimates 
calorie needs based on oxygen consumed and CO2 produced.  Then subjects will be instructed 
on how to keep a 3-day food record and complete the Qualtrics survey designed for this purpose 
within 2 weeks of consenting.  Dietetic interns will calculate nutrient content of the participants’ 
typical diet, based on the 3-day, Qualtrics-based food/beverage log, using Food Processor 
software. Meals for the acclimation period will be created to mimic the participants’ typical diet 
(daily calories and percent of calories from carbohydrate, protein and fat), as well as to meet 
their calorie needs per the indirect calorimeter test, for the first 7-9 days of the study (Figure 1). 
High protein diets (2g/kg/day) will then be devised and provided for the next 14-16 days. 
Following this period, low protein diets (o.8g/kg/day) will be devised and provided for the next 
14-16 days (Figure 1). Fat content will be modulated to keep diets isocaloric while keeping 
carbohydrate content stable. Participants will choose between two 3-day cycle menus for each 
feeding phase. Meals will be prepared by Megan Bennett, RD, Chef in a metabolic kitchen 
housed in SBU’s Business Incubator at Calverton with the help of SBU dietetic interns. Meals 
will be prepared in batches, packaged and frozen at the incubator, then transported in a cooler 
with thermometers by members of the Nutrition Division to the Food Service Department at 
SBU Hospital. Meals will be kept frozen in freezers until the day they are provided to 
participants.  Each day of the feeding period, dietetic interns will take all meals for all 
participants for that day from the freezers and place them in a cooler with a thermometer to bring 
them to a campus dining area. Logs of temperatures of coolers will be maintained daily, with 
temperatures checked every hour. 

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In order to provide meals, participants will come to room 3-064C in the HSC building on 
the East side of the Stony Brook University campus (conference room located in the office suite 
of the Division of Nutrition) a semi-private area on the 2nd floor of the Student Activity Center 
between 8:30-11AM to eat breakfast onsite and pick up other meals and snacks for the rest of the 
day, from a dietetic intern. Participants will be provided a closed envelope containing a form that 
will list their participant ID# and age in which they’ll sign in and indicate if they’ve begun any 
new medications or been diagnosed with a disease since starting the study (form attached). 
Additionally, every Monday and Thursday, participants will be weighed using a digital scale in a 
private area within the Division of Nutrition Suiteon the 2nd floor of the Student Activity Center, 
in order to track changes in body weight while on the study. If weight changes greater than 2% 
of baseline, calorie content of the meals will be modified to avoid further weight changes. Food 
for the rest of the day will be provided in an insulated bag containing frozen cold packs and 
participants will be instructed to keep lunch and dinner in the insulated bag or a refrigerator until 
eaten. They will be instructed to heat the respective meals in a microwave until hot, prior to 
consumption. They will be instructed to take a picture of each meal before and after eating and 
upload the pictures via a Qualtrics-based survey, in order for the study team to estimate how 
much food has been eaten at each meal. Although participants will be instructed to only eat the 
food and beverages provided for the study, they will log any consumption of food or beverages 
not provided for the study via this same Qualtrics-based survey. Consumption of water, black 
coffee and tea will not be logged.  
 
During days 7-9, 24-26 and 41-43 (Figure 1) participants will provide a stool sample to 
be placed into a sterile container (provided by the study team) then placed into an opaque brown 
paper bag and brought to the Division of Nutrition Suite student health services within 1 hour, 
where it will be kept cold in a cooler until refrigerated until picked up by the study team to be 
stored at -80ºC. On the same day as providingAt the same time the stool sample is delivered, 
blood will be drawn by a phlebotomist at Student Health Services to generate plasma. An order 
for the blood draw will be placed by a physician at Student Health Services. The physician will 
not have any interaction with the study subject. After the blood draw, the phlebotomist at Student 
Health Services will call and email a member of the Montrose Lab to report the sample 
collection and samples will kept at 4º C until picked up. Stool and pPlasma samples will be 
picked up by a member of the Montrose Lab within 1 hour of being contacted. Plasma will be 
distributed into 2mL screw cap tubes in 4 equal aliquots and stool sample will be cut in half and 
stored in two 50mL tubes and all samples will be placed into a -80ºC freezer until analysis. If a 
participant provides samples in the earlier part of the collection period (e.g. day 7) they may 
proceed immediately to the next phase of the study.  
 
 
Figure 1. Experimental design. 

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10.1 
Describe what data, including long-term follow-up, will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, consider 
the addition of a schedule or table in your response. 
Response: Primary endpoints: 
Circulating metabolite levels in blood 
Fecal microbiota profiling by 16S rRNA analysis & metatranscriptomics 
Fecal metabolite levels 
 
 
 
 
List, and upload, any instruments or measurement tools used to collect data (e.g. survey, 
scripts, questionnaire, interview guide, validated instrument, data collection form).   
Response: These documents have been uploaded. 
 
 
10.2 
Describe any source records that will be used to collect data about subjects (e.g. 
school records, electronic medical records) and include the date range for records that 
will be accessed.. 
Response: N/A 
 
 
10.3 
Indicate whether or not the results for individual subjects, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be shared with 
subjects or others (e.g., the subject’s primary care physician) and if so, describe how 
these will be shared. 
Response: N/A 
 
 
10.4 
Indicate whether or not generalized study results will be shared with subjects or 
others, and if so, describe how these will be shared. 
Response: N/A 
 
 
11.0 Study Timelines 
 
11.1 
Describe the anticipated duration of the study needed to enroll all study subjects. 

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Response: We anticipate that we will enroll all participants within a 3 month period and before 
the end of Fall semester.  
 
 
11.2 
Describe the duration of an individual subject’s participation in the study. Include 
length of study visits, and overall study follow-up time. 
Response: The maximum length of time a participant will be on the study is 6 weeks (see Figure 
1 above). Subjects will commit approximately 30 minutes each morning to eat breakfast and 
collect the rest of the meals for the day. They will commit approximately 30-60 minutes on 3 
occasions to deliver stool sample sand have blood drawn. After completing the study, no follow 
up will be needed.  
 
11.3 
Describe the estimated duration for the investigators to complete this study (i.e. 
all data is collected and all analyses have been completed). 
Response: We anticipate that primary endpoints will be generated within 1 year of initiating 
subjects on the study.  
 
 
12.0 Research Setting 
 
12.1 
Describe all facilities/sites/locations where you will be screening and conducting 
research procedures.  Include a description of the security and privacy of the facilities 
(e.g. locked facility, limited access, privacy barriers).  Facility, department, and type of 
room are relevant.  Do not abbreviate facility names.   
Example: “A classroom setting in the Department of Psychology equipped with a 
computer with relevant survey administration software,” “The angiogram suite at 
Stony Brook University Hospital, a fully accredited tertiary care institution within 
New York State with badge access,” 
Response: The in-person interview will be conducted in room 206 (private office) of the Earth 
and Space Science (ESS) building at Stony Brook University. Meals will be provided in a semi-
private reserved area on the 2nd floor of the Student Activity Center. Stool samples will be 
delivered and blood samples taken at Student Health Services, a location already established to 
ensure confidentiality.  
 
 
12.2 
For research procedures being conducted, for this study, external to SBU and its 
affiliates (e.g., in schools, out-of-state, internationally, etc.) describe:  
• Site-specific regulations or customs affecting the research 
• The composition and involvement of any community advisory board 
• Local scientific and ethical review structure outside the organization. 

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• Local issues affecting the research and rights of research subjects.  
NOTE:  This question is not referring to multi-center research.  If this research is 
being conducted internationally, Supplemental Form C must be completed and 
uploaded.  
Response:  
 
☒ 
N/A:  This study is not conducted outside of SBU or its affiliates. 
 
13.0 Resources and Qualifications 
 
13.1 
The Principal Investigator (PI) must confirm, in consultation with Chair and 
Dean as applicable, that adequate resources are present to conduct and complete the 
study compliantly and safely. Specifically: 
☐ NO ☒YES The proposed subject population(s) are available in sufficient numbers to 
meet the study requirements  
☐ NO ☒YES Sufficient funds are available to conduct and complete the study 
compliantly and safely  
☐ NO ☒YES The PI and study team have sufficient time to conduct and complete the 
study compliantly and safely  
☐ NO ☒YES The PI has determined that the named study team is qualified to conduct 
the research compliantly and to monitor the safety and welfare of the enrolled research 
subjects effectively. 
☐ NO ☒YES The PI ensures that the study team is fully aware of his/her involvement in 
this study and the details of the study protocol  
☐ NO ☒YES The PI ensures that the study teams will only be involved in research 
procedures for which they have been trained, and are currently certified and/or licensed, 
if required..  
 
13.2 
Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if applicable. 
(e.g, “on-call availability of a counselor or psychologist for a study that screens subjects 
for depression”). 
Response: We don't anticipate any adverse events given the nature of this study, but subjects will 
have access to any medical care that is needed through Student Health Services.  
 
 
13.3 
Describe your process to ensure that all study team members are updated on the 
progress of the research and the regulatory requirements (including enrolled subjects, 
unanticipated problems etc.)  

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Response: The study team will meet weekly to review the progress of recruitment, enrollment 
and sample collection. The PI will update the rest of the study team when data related to primary 
endpoints are generated.  
 
 
14.0 Other Approvals 
14. 
 List  approvals that will be obtained prior to commencing the research (e.g., 
University Hospital sign-offs per the UH Application, Cancer Center Scientific review, 
school, external site, funding agency, laboratory, Radiation Safety, IBC, SCRO, IACUC, 
RDRC). 
Response:  
 
☒ 
N/A:  This study does not require any other approvals. 
 
15.0 Provisions to Protect the Privacy Interests of Subjects 
 
15.1 
Describe how you will protect subjects’ privacy interests during the course of this 
research and any steps you will take to make the subject feel at ease. 
NOTE:  Privacy refers to an individual’s desire/right to control access to or to place 
limits on whom they interact with or whom they provide personal information.  Privacy 
applies to the person.  Confidentiality refers to how data collected about individuals for 
the research will be protected by the researcher from release.  Confidentiality applies to 
the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a private office setting where no one can overhear”, or “the participant is 
reminded that they are free to refuse to answer any questions that they do not feel 
comfortable answering.”   
Response: In person screening will take place in a private office in which no one can overhear 
the discussion taking place. If they do not feel comfortable answering the health questionnaire 
they will be reminded that they do not have to. Meals will be provided in a semi-private area so 
participants don't feel uncomfortable receiving meals in an atypical manner. Blood will be drawn 
in a private room in a confidential manner.  
 
 
16.0 Data Management and Analysis 
 
16.1 
Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  

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Response: For our primary endpoint of measuring circulating amino acid levels, data will be 
transformed to reflect log2 fold change values at each of the 2 time points following 
administration of the experimental diets, compared to the levels at baseline. Paired t-tests will be 
used to determine whether significant changes occur.  
 
16.2 
If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records reviews, 
survey studies, or observational studies.  This question is asked to elicit whether the 
investigator has an adequate sample size to achieve the study objectives and justify a 
conclusion.  
Response: The statistical analysis for the primary aim of the study will compare circulating 
amino acid levels in subjects after consuming high or low protein diets for 2 weeks. We will 
enroll 14 subjects with the prediction that 10 will complete the study. A sample size of 10 
subjects will allow 80% power to detect minimum differences of 0.996 standard deviations in 
plasma amino acid levels at 5% significance with the use of paired t-tests.  
 
 
 
17.0 Confidentiality 
   A. Confidentiality/Security of Study Data 
 
Describe the local procedures for maintenance of security and confidentiality of study 
data and any records that will be reviewed for data collection.   
 
17.1 
Where and how will all data and records be stored?  Include information about:  
password protection, encryption, physical controls, authorization of access, certificates 
of confidentiality, and separation of identifiers and data, as applicable.  Include physical 
(e.g. paper) and electronic files. 
Response: Qualtrics uses "Transport Layer Security" encryption for all transmitted data, and is 
hosted by Stony Brook University Division of Information Technology for the purpose of 
conducting research.  Subjects will enter their ID number on every survey and this will be data to 
be downloaded and organized by subject ID in an Excel spreadsheet.  Electronic documents will 
be stored on a password-protected share drive and access to the drive will be limited to members 
of the study team. Paper records will be stored in a locked filing cabinet in the office suite of the 
Division of Nutrition. All documents will be de-identified and coded except for a master 
electronic document containing the key to the codes, which will be stored on a password-
protected drive by the PI.  
 
 
17.2 
How long will the data be stored? 

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Response: Data will be stored indefinitely to allow for endpoints to be assessed at a later time 
point.  
 
 
17.3 
Who will have access to the data? 
Response: Members of the study team listed in "myResearch" proposal 
 
 
17.4 
Who is responsible for receipt or transmission of the data? 
Response: Members of the study team listed on "myResearch" proposal 
 
 
17.5 
How will the data be transported/transmitted? 
Response: Participant-generated data (i.e. responses to screening questions) will be submitted via 
Qualtrics. Data input or analysis carried out by members of the study team will be done on SBU 
tagged computers and files saved to the password-protected drive.  
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study specimens.   
 
☐ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 18.0) 
 
17.6 
Where and how will all specimens be stored?  Include information about:  
physical controls, authorization of access, and labeling of specimens, as applicable.   
Response: Tubes containing subject specimens will be de-identified by replacing the subjects' 
name with a numbered code. The tubes will be stored in a -80º C freezer located in room 9-166 
in the BST.  
 
 
17.7 
How long will the specimens be stored? 
Response: Indefinitely 
 
 
17.8 
Who will have access to the specimens? 
Response: Members of the study team listed on "myResearch" proposal 
 
 
17.9 
Who is responsible for receipt or transmission of the specimens? 

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                                                                 Page 17 of 28 
 
Response: Members of the study team listed on "myResearch" proposal 
 
 
17.10 How will the specimens be transported? 
Response: Specimens will be picked up from Student health services and transported to the 
Montrose lab by members of the study team listed on "myResearch" proposal.  
 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects  
☒ 
N/A:  This study is not enrolling subjects OR is limited to records review procedures 
only OR is a minimal risk study 
 
18.1 
Describe the plan to evaluate the data periodically regarding both harms and 
benefits to determine whether subjects remain safe. The plan might include establishing a 
data safety monitoring committee and a plan for reporting data monitoring committee 
findings to the IRB and the sponsor. 
Response: N/A 
 
 
 
18.2 
Describe what data are reviewed, including safety data, untoward events, and 
efficacy data. 
Response: N/A 
 
 
18.3 
Describe any primary or secondary safety endpoints. 
Response: N/A 
 
 
18.4 
Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: N/A 
 
 
18.5 
Describe the frequency of safety data collection, including when safety data 
collection starts. 
Response: N/A 
 
 
18.6 
Describe who will review the safety data. 
Response: N/A 

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                                                                 Page 18 of 28 
 
 
18.7 
Describe the frequency or periodicity of review of cumulative safety data. 
Response: N/A 
 
 
18.8 
Describe the statistical tests for analyzing the safety data to determine whether 
harm is occurring. 
Response: N/A 
 
 
18.9 
Describe any conditions that trigger an immediate suspension of the research. 
Response: N/A 
 
 
19.0 Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
19.1 
Describe anticipated circumstances under which subjects may be withdrawn from 
the research without their consent. 
Response: Subjects may be withdrawn from the study if they begin taking antibiotics or are 
diagnosed with a significant illness of the gastrointestinal tract while on the study. Additionally, 
if subjects fail to pick up their meals or eat the provided meals for more than 2 days in a row, 
they will be removed from the study.  
 
 
19.2 
Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for physical or 
emotional health. 
Response: The subject will be contacted and informed of their removal from the study. No 
follow up will be needed. 
 
 
19.3 
Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial withdrawal from 
procedures with continued data collection, as applicable. 
Response: If a subject is removed from the study before the second specimen collection, the 
specimens and dietary data from that individual will not be used for analysis. Already collected 
specimens will be destroyed. If a subject is removed from the study following the second 

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                                                                 Page 19 of 28 
 
specimen collection but before the last collection, the samples from the first 2 collections and 
dietary data collection up to withdrawal will still be analyzed.   
 
 
19.4 
Describe what will happen to data already collected.  
Response: Data from specimen analyses will not be generated until all subjects have completed 
the study. If a subject is removed from the study following the second specimen collection but 
before the last collection, the samples from the first 2 collections will still be analyzed and 
dietary data collected up until that point will be analyzed. 
 
 
 
20.0 Risks to Subjects 
 
20.1 In your opinion, what is the overall risk (physical and nonphysical) to research 
subjects in this study (minimal, greater than minimal or unknown)  
Response: Minimal 
 
 
20.2 Describe if any subjects are withdrawn from therapeutic procedures or drugs (e.g., 
washout periods) prior to, or during, their participation in the study.   
Response: N/A 
 
 
20.3 List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the 
subjects related to their participation in the research. Consider physical, psychological, 
social, legal, and economic risks.  Include a description of the probability, magnitude, 
duration, and reversibility of the risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response: The requirement to collect meals each day will be a minimal but temporary 
inconvenience. Subjects will experience mild discomfort upon having blood drawn due to the 
insertion of the needle and the potential to develop bruising in that area (as described on the 
consent form). Such effects will be temporary and are not expected to have a significant impact 
on the individual. There is no risk or discomfort in performing the indirect calorimetry test. 
 
 
20.4 Describe procedures performed to minimize the probability or magnitude of risks, 
including procedures being performed to monitor subjects for safety. 
Response: The minimal risks described above cannot be avoided due to the nature of the study 
but are not expected to have any major impact on the subject.  
 

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20.5 If applicable, indicate which procedures may have risks to the subjects that are 
currently unforeseeable. 
Response: We do not anticipate that this will occur.  
 
 
20.6 Indicate which research procedures, if any, may have risks to an embryo or fetus 
should the subject be or become pregnant. 
Response: N/A 
 
☒ 
N/A 
 
20.7 If you responded to 20.6 that there are such risks, how will you minimize the risk of 
a pregnancy occurring during the course of the study?  (Select all that apply) 
 
☐ 
Counseling on birth control and /or abstinence 
☐ 
Pregnancy test during the study 
☐ 
Pregnancy test prior to initiation of the study 
☐ 
Other   _____ 
☒ 
N/A    
 
20.8 If applicable, describe possible risks to others who are not subjects. 
Response: N/A 
 
 
21.0 Potential Benefits to Subjects 
 
21.1 
Describe the potential benefits that individual subjects may experience by taking 
part in the research.  Include the probability, magnitude, and duration of the potential 
benefits.   
Response: No benefit 
 
 
21.2 
Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response: No direct benefit 
 
Indicate if there is a potential benefit to others, future science or society.    

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                                                                 Page 21 of 28 
 
Response: The ability to demonstrate that reducing dietary protein lowers circulating amino acids 
levels in healthy volunteers will lay the foundation for testing this approach in cancer patients 
with the goal of enhancing cancer therapy and improving outcome. 
 
 
22.0 Compensation for Research-Related Injury 
☒ 
N/A:  The research procedures for this study do not present risk of research related 
injury. This section does not apply.   
 
22.1 
If the research procedures carry a risk of research related injury, describe the 
available compensation to subjects in the event that such injury should occur.   
Response: N/A 
 
 
22.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language regarding 
research related injury, you must modify your response here and submit an amendment to 
the IRB for review and approval. 
Response: N/A 
 
 
23.0 Economic Burden to Subjects 
 
23.1 
Describe any costs that subjects may be responsible for because of participation 
in the research.   
NOTE:  Some examples include transportation or parking. 
Response: Subjects are not expected to have significant costs associated with participating in this 
study.  
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review procedures only.  
This section does not apply. 
 
24.0 Compensation for Participation 
☐ 
N/A:  There is no compensation for participation.  This section does not apply.  
 

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                                                                 Page 22 of 28 
 
24.1 
Describe the amount/nature and timing/scheduling of any compensation to 
subjects, including monetary, course credit, or gift card compensation. Describe any 
prorated payments based on participation. 
Response: Subjects will be given $100 every 2 weeks (up to 6 weeks or $300) while participating 
in the study. Additionally, they will be provided with all meals and snacks over a 6 week period, 
which represents an approximate value of $1,000.  
 
 
24.2 
Justify the amount and scheduling of payments described above to ensure that 
they are reasonable and commensurate with the expected contributions of the participant. 
If multiple visits are involved payments should be prorated. 
Note: If using West Campus Departmental pools, participation in studies may be offered 
for credit in class but students MUST be given other options for fulfilling the research 
component that are comparable in terms of time, effort, and education benefit.  Please 
list alternative activities 
Response: The compensation being provided to the participants is significant enough to 
compensate them for their time and any inconvenience they may experience. The payment 
schedule helps to ensure that subjects will complete the study. Moreover, there is significant 
value of the food being provided to them. 
 
 
25.0 Informed Consent 
 
25.1   Will you be obtaining consent from subjects?   
☒ 
Yes 
(If yes, Provide responses to each question in this Section, and upload 
your consent documents where indicated in the electronic submission system) 
☐ 
No 
(If no, Skip to next section) 
 
25.2 
Describe how the capacity to consent will be assessed for all subjects. Review for 
guidance http://research.stonybrook.edu/human-subjects-standard-operating-
procedures/determining-potential-adult-subjects-ability-consent: 
Response: Subjects are being recruited from the pool of Stony Brook undergraduate and graduate 
student population, and need to complete a web-based Qualtrics survey to be considered and 
consented.  By navigating completion of this survey and having student status, subjects will be 
demonstrating the ability to consent for this study.   
 
 
25.3 
Describe the consent process that will be conducted to ensure that subject is fully 
informed regarding study details and subject rights. Include where the consent process 
will take place, with consideration of the need to protect the subject’s right to privacy.  

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                                                                 Page 23 of 28 
 
Response: Subjects will be consented by trained dietetic interns of the Nutrition Division of 
SBU. Interns will be trained on how to consent by supervisors of the internship program who are 
also research team members and experienced researchers. The consenting process will take place 
in a private office (described above) with the door closed to ensure privacy. The consent form 
will be read to the potential subject and a detailed description of the study will be made so that 
the individual is fully aware of the requirements and their role in the study.  
 
 
25.4 
Describe how you will ensure that subjects are provided with sufficient time to 
consider taking part in the research study.  Detail if there is there any time period 
expected between informing the prospective subject and obtaining the consent.   
NOTE:  It is respectful to the prospective subject to ensure that sufficient time is given to 
have their questions answered and to consider their participation 
Response: Individuals will make an appointment for the final screening and consent process.  
Potential subjects will be given the time to have all their questions addressed, and the study fully 
explained.  Subjects will be asked if they need additional time to consider consenting, and if they 
express the need for more time, they will be given a second appointment within 1 week. 
 
 
 
25.5 
Describe the process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: When participants arrive to eat breakfast and pick up their meals each day, they will 
be asked whether they are comfortable continuing on the study.  
 
Non-English Speaking Subjects  
☐ 
N/A:  This study will not enroll Non-English speaking subjects.   
 
25.6 
Indicate which language(s) other than English are likely to be spoken/understood 
by your prospective study population or their legally authorized representatives. 
Response: Given that the target population is made of students, they will have a working 
knowledge of English.  
 
 
25.7 
If subjects who do not speak English will be enrolled, describe the process to 
consent the subjects, as well as the process to be used to ensure their understanding of 
research procedures throughout the conduct of the study. Review SOP’s section 17.8 for 
important policies in this regard: http://research.stonybrook.edu/human-subjects-
standard-operating-procedures/policy-non-english-speakers-research-subjects for SBU 
policy on inclusion of non-English speakers.  

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                                                                 Page 24 of 28 
 
Response: N/A 
 
Adults Unable to Consent  
☒ 
N/A:  This study will not enroll adults unable to consent.  
 
25.8 
Justify why it is necessary to include adult subjects who are unable to consent. 
Response: N/A 
 
 
25.9 
Describe how you will identify Legally Authorized Representatives (LAR) for the 
subjects that will be consistent with the NYS Family Health Care Decisions Act (FHCDA; 
see http://research.stonybrook.edu/human-subjects-standard-operating-
procedures/definitions-2).  Indicate why it is necessary to include subjects who are 
unable to consent. 
Note:  For research conducted outside of New York State, provide information that 
describes which individuals are authorized under applicable law to consent on behalf of 
a prospective subject to their participation in the research.   
Response: N/A 
 
 
25.10 Describe the process for obtaining assent from the adult subjects 
Indicate whether assent will be obtained from all, some, or none of the subjects.  If some, 
indicate which adults will be required to assent and which will not. 
Response: N/A 
 
If assent will not be obtained from some or all subjects, provide an explanation of why 
not. 
Response: N/A 
 
 
25.11 Describe whether assent of the adult subjects will be documented and the process 
to document assent.   
Response: N/A 
 
 
25.12 Describe how you will obtain consent from a subject to use their data if they later 
become capable of consent.  How will competence be assessed and by whom?  
Response: N/A 
 
 

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                                                                 Page 25 of 28 
 
26.0 Waiver or Alteration of Consent Process 
Complete this section if: 
• Informed consent will not be obtained at all 
• Informed consent will be obtained, but not documented, or 
• consent will be obtained, but not all required information will be disclosed (e.g., in 
deception research) 
☒ N/A:  A waiver or alteration of consent is not being requested. 
 
26.1 
Review, complete, and upload SUPPLEMENTAL FORM G: Consent Waivers  
☐  
 Confirmed 
 
26.2 
If the research involves a waiver of the consent process for planned emergency 
research, please contact the Office of Research Compliance for guidance regarding 
assistance in complying with federal regulations governing this activity (see: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.24)  
 
27.0 Multi-Site Research (Multisite/Multicenter Only) 
☒ N/A:  This study is not an investigator-initiated, multi-site study.  This section does 
not apply. 
 
27.1 
If this is a multi-site study where SBU is the lead site and/or the IRB of record, 
describe the processes to ensure communication among sites. Include:  
• All sites have the most current version of the IRB documents, including the 
protocol, consent document, and HIPAA authorization. 
• All required approvals have been obtained at each site (including approval by the 
site’s IRB of record). 
• All modifications have been communicated to sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented. 
• All engaged participating sites will safeguard data as required by local 
information security policies. 
• All local site investigators conduct the study appropriately. 
• All non-compliance with the study protocol or applicable requirements will be 
reported in accordance with local policy. 
Response: N/A 
 
 
27.2 
Describe the method for communicating to engaged participating sites: 
• Problems 
• Interim results 

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                                                                 Page 26 of 28 
 
• Study closure 
Response: N/A 
 
 
27.3 
Indicate and statistically justify the total number of subjects that will be enrolled 
or records that will be reviewed across all sites. 
Response: N/A 
 
 
28.0 Banking Data or Specimens for Future Unspecified Use 
☒ 
N/A:  This study is not storing data or specimens for research outside the scope of 
the present protocol.  This section does not apply. 
 
IMPORTANT: If you are proposing to bank specimens for future use, you may be 
subject to licensure requirements under the NYS Department of Health, and must 
be covered under the SBU license. See SOPs at 
http://research.stonybrook.edu/human-subjects-standard-operating-
procedures/data-tissue-registries-banks 
 
28.1 
If data will be banked  for research outside of the scope of the present protocol, 
describe where the data will be stored, how long they will be stored, how will they be 
accessed, and who will have access to the data  
NOTE:  Your response here must be consistent with the information provided to subjects 
in your Consent Documents  
Response: N/A 
 
 
28.2 
If specimens will be banked (stored) for research outside of the scope of the 
present protocol, describe where the specimens will be stored, how long they will be 
stored, identifiers that will be associated with each specimen, how will they be accessed, 
and who will have access to the specimens  
 
NOTE:  Your response here must be consistent with the information provided to subjects 
in your 
 Consent Documents 
Response: N/A 
 
28.3 
Describe the procedures to release banked data and/or specimens for future uses, 
including: the process to request a release, approvals required for release, who can 
obtain data or specimens, and the data to be provided with specimens. 

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                                                                 Page 27 of 28 
 
Response: N/A 
 
 
29.0 Drugs and Devices 
☒ 
N/A:  This study does not involve drugs or devices.  This section does not apply. 
 
29.1 
Does this study involve use of radiopharmaceuticals? ☐ Yes  ☒ No 
  
29.2 
For investigational devices (including marketed devices being used off label), 
Provide the following information below: 
Where will the device(s) be stored? Note that the storage area must be within an area 
under the PI’s control      
Describe the security of the storage unit/facility      
Provide full detail regarding how the dispensing of the device(s) will be controlled 
(accountability of removal/return of used devices, and disposition of remaining devices at 
the conclusion of the investigation)  and documented (accounting records/logs)    
Response: N/A 
 
 
29.3 
For investigational drugs (including marketed drugs being used off label), will the 
services of the Investigational Drug Pharmacy be used for storage, dispensing, 
accounting the drug (required for research conducted at UH, HSC, Cancer Center, and 
Ambulatory Surgery Center)?  
 
☐  
Yes   
☐ 
No →PI Provide the following information below:  
• Where will the drugs/biologics be stored? Note that the storage area must be 
within an area under the PI’s control       
• Describe the security of the storage unit/facility:       
• Provide full detail regarding dispensing of the drugs(s), how labeled, controlled 
(accountability, disposition of unused drug at the conclusion of the investigation)  
and documented (accounting records/logs):        
Response: N/A 
 
 
30.0 Sharing of Results with Subjects    
 
30.1 
Describe whether results (study results or individual subject results, such as 
results of investigational diagnostic tests, genetic tests, or incidental findings) will be 

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                                                                 Page 28 of 28 
 
shared with subjects or others (e.g., the subject’s primary care physicians) and if so, 
describe how it will be shared. 
Response: Results will not be shared with subjects.