Time Restricted Eating Outcomes in Multiple Sclerosis
Phase: NA
Conditions: Multiple Sclerosis, Diet, Healthy
Sponsor: University of Alabama at Birmingham

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Title: Time Restricted Eating Outcomes in Multiple Sclerosis (TREO MS) 
 
NCT number: NCT04389970 
 
Date: 5/5/2020 
 
 
 

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Human Subjects Protocol (HSP) 
Form Version: July 29, 2019 
 
 
• 
To avoid delay, respond to all items in order and include all required approvals and documents. For more tips, see the UAB IRB website. 
• 
To complete the form, click the underlined areas and type or paste in your text; click checkboxes to check/uncheck. 
• 
All responses should be Times New Roman, Bold, and Underlined. 
• 
NOTES REGARDING VA RESEARCH: BVAMC research cannot be reviewed by an external IRB (only UAB IRB). Ensure you complete this form for any 
BVAMC research. BVAMC Research must be signed off by the BVAMC supervisor for scientific/scholarly review via PORF prior to submission of this 
form. 
 
 
INDICATE THE TYPE OF REVIEW YOU ARE APPLYING FOR: 
☒ Convened (Full) IRB 
    OR 
☐ Expedited - See the Expedited Category Review Sheet, and indicate the category(ies) here: 
☐1 ☐2 ☐3 ☐4 ☐5 ☐6 ☐7 
 
 
1. IRB Protocol Title: Time Restricted Eating Outcomes in Multiple Sclerosis (TREO MS) 
 
2. Investigator and Contact Person 
a. Name of Principal Investigator: Brooks Wingo 
Degree(s)/Title: PhD  
BlazerID: kbcotton 
Dept/Div: Occupational Therapy 
Mailing Address: SHPB 385  
UAB ZIP: 1212 
Phone: 4-5982 
 
 
 
E-mail: bcwingo@uab.edu 
 
b.   Name of Contact Person: Kathryn Green 
Title: Research Coordinator  
 
Phone: 205-319-14-24      E-mail: kathryngreen@uabmc.edu 
 
 
 
 
 
 
INVESTIGATOR ASSURANCE STATEMENT & SIGNATURE 
By my signature as Principal Investigator, I acknowledge my responsibilities for this Human Subjects Protocol, 
including: 
• Certifying that I and all key personnel comply with reporting requirements of the UAB Conflict of Interest Review 
Board; 
• Certifying that the information, data, and/or specimens collected for the research will be used, disclosed and 
maintained in accordance with this protocol and UAB policies; 
• Following this protocol without modification unless (a) the IRB has approved changes prior to implementation or 
(b) it is necessary to eliminate an apparent, immediate hazard to a participant(s); 
• Verifying that all key personnel listed on the submission have completed initial IRB training and will complete 
continuing IRB training as required; 
• Verifying that all personnel are licensed/credentialed for the procedures they will be performing, if applicable; 
• Certifying that I and all key personnel have read the UAB Policy/Procedure to Ensure Prompt Reporting of 
Unanticipated Problems Involving Risks to Subjects or Others to the IRB, Institutional Officials, and Regulatory 
Agencies and understand the procedures for reporting; 
• Applying for continuing review of the protocol at least annually unless directed by the IRB to apply more 
frequently; 
• Conducting the protocol as represented here and in compliance with IRB determinations and all applicable local, 
state, and federal law and regulations; providing the IRB with all information necessary to review the protocol; 
refraining from protocol activities until receipt of initial and continuing formal IRB approval.  
 
Signature of Investigator:  
 
 
 
 
 
 
 
Date:  5-5-2020 
 
 

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3. Protocol Personnel 
a. Complete the IRB PERSONNEL FORM to list all key personnel (each individual involved in the design and conduct of this protocol).  
b. Non-UAB Personnel Relying on UAB IRB - If you are requesting that the UAB IRB serve as the IRB of record for any non-UAB personnel, list these 
individuals below. Add additional rows as necessary. 
Name and Degree 
From Institution with or without own IRB? 
 
Financial Interest?* 
Protocol Responsibilities and 
Qualifications (indicate if this 
person obtains consent) 
 
 
 
 
* If the individual has a Financial Interest, include a copy of the report from his/her own institution’s conflict of interest review with this submission to 
the UAB IRB. 
 
VA Personnel: The VA Financial Conflict of Interest (fCOI) form must be submitted to the VA fCOI Committee Chair. Include in 3.a above any financial 
conflict of interest as submitted on that VA fCOI form. If there is a conflict, submit a copy of the management plan with this submission.  
 
c. Are any of the investigators listed on the IRB PERSONNEL FORM students using this research for their thesis or 
dissertation?  
 
 
 
 
 
 
 
 
 
 
       ☐Yes ☒No 
 
If No, continue with Item 3d. 
 
If Yes, provide the name of the student and the Thesis/Dissertation Title:       
 
d. Is the principal investigator a student, fellow, or resident? 
☐Yes ☒No 
If Yes, complete items below and obtain signature of faculty advisor or supervisor: 
 
 
 
Supervisor’s Name:       
 
 
Supervisor’s Signature:_____________________________________________ 
 
e. Is medical supervision required for this research? 
☐Yes ☒No 
If Yes, who will provide the medical supervision? 
☐ PI will provide -OR- 
☐ Other: 
Name:       Telephone:       
If other than PI, obtain signature of person providing medical supervision: 
Signature  
 
 
 
 
 
 
 
 
f. Describe the principal investigator's activities related to this protocol and provisions made by the PI to devote 
sufficient time to conduct the protocol: Dr. Wingo will devote 10% of her time to this study.  She will 
work with the research coordinator (K. Green) to oversee all aspects of participant recruitment, 
protocol development and data collection. She will oversee training of all study staff who will be directly 
involved with participants, and she will be responsible for quality control of data collection procedures. 
 
g. Describe your process for ensuring all key personnel are adequately informed about the protocol and their 
research-related duties and functions: All persons assisting with the research will receive a copy of the 
study protocol where their roles are detailed. We will hold weekly meetings at the start-up of the study 
to ensure research-related duties and functions are understood. We will create a Manual of Operations 
which details duties and functions to be carried out during the study. 
 
4. Funding 
Is this protocol funded? 
☒Yes ☐No 
 
If No, specify that costs of the protocol will be covered by funds from the UAB department or other source 
named:       
 
If Yes, attach one copy of completed application or request for funding sent to sponsor, and complete a-d. 
a. Title of Grant, Contract, or Agreement: Time Restricted Eating Outcomes in Multiple Sclerosis (TREO 
MS) 
 

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b. UAB PI of Grant, Contract, or Agreement: Brooks Wingo 
 
c. Office of Sponsored Programs (OSP) Assigned Number: NA (intramural award from UAB NORC) 
(If not yet available, enter “Pending” and provide upon receipt from OSP.) 
 
d. Sponsor, Funding Route: 
(Check and describe all that apply) 
(If subaward, list both the funding source and the institution receiving the direct award) 
☐ Gov’t Agency or Agencies—Agency name(s):       
☐ Department of Defense (DoD): Identify DoD component:       
☐ Department of Energy (DOE) 
☐ Department of Justice (DOJ) 
☐ Department of Education 
☐ NIH Cooperative Group Trial - Group name:       
☐ Private Nonprofit (e.g., Foundation) - Name:       
☐ Industry-sponsored, industry-initiated - Name:       
NOTE:  The UAB IRB typically only reviews industry-sponsored protocols that are investigator initiated or 
when the protocol qualifies for expedited review or involves gene therapy. 
☐ Industry-sponsored, investigator-initiated - Name:       
Describe the funding arrangement:       
NOTE:  The UAB IRB typically only reviews industry-sponsored protocols that are investigator initiated or 
when the protocol qualifies for expedited review or involves gene therapy. 
☒ UAB Departmental/Division Funds—Specify: UAB Nutrition Obesity Research Center (NORC) 
☐ VA Funding —Specify:       
 
5. Locations Involved 
a. Indicate all performance sites that will provide space, services, or facilities for the conduct of this protocol. 
☐ UAB Hospital 
☐ UAB Hospital - Highlands 
☒ The Kirklin Clinic of UAB Hospital 
☐ The Kirklin Clinic at Acton Road 
☐ UAB Callahan Eye Hospital 
☐ UAB Clinical Research Unit 
☐ Children's of Alabama 
☐ Birmingham Veterans Affairs Medical Center NOTE: Research may only be conducted by investigators who 
have a BVAMC appointment 
☐ Jefferson County Department of Health 
☒ Other (i.e., any performance site not listed above, including those covered by subawards related to this 
protocol) - Describe: UAB Wallace Research Lab at Lakeshore Foundation, School of Health 
Professionals Building, Webb Bldg. 
NOTE:  Documentation of IRB approvals from sites receiving subawards must be received by the UAB OIRB 
before funding will be released for that subaward. 
 
b. Describe the space, service, or facilities available for the conduct of the research in the performance sites 
listed in Item 5.a (For research on UAB campus, include building names):  
UAB MS Clinics in TKC will assist with recruitment by placing flyers in the waiting rooms.  
UAB Wallace Research Lab: All baseline and endpoint data collection will be conducted in the Wallace 
lab.  Paper records will also be stored here until the study is complete. The research coordinator’s office 
is also at Wallace.  
SHPB: The PI’s office is in SHPB. All paper study records will be moved here once the study is 
complete.  

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Webb: Blood samples will be stored and analyzed in the Webb Bldg. 
 
c. Does this protocol require clinical services at one of the sites listed in Item 5.a above? 
☐Yes ☒No 
If Yes, will any of the services be billed to either participants/their insurance or to the study account through 
the Hospital Billing Office (PFS) or the HSF Billing Office (MSO)? 
☐Yes ☐No 
 
If Yes, submit a Fiscal Approval Process (FAP)-designated unit submission and send to fap@uab.edu. For 
more on the UAB FAP requirements, go to FAP - SiteMinder Processes. 
 
d. Is this a field study? 
☐Yes ☒No 
If Yes, describe the community and include information about how the community will be involved in the 
design, implementation and analysis of the research. This would include focus groups, training local 
facilitators/community health advisors:       
 
e. Has this protocol been rejected or disapproved by another review board (another IRB, similar review board, or 
departmental review committee(s)) that authorizes the use of its patient populations? 
☐Yes ☒No 
 
If Yes, provide name(s) of the review board(s) and reason(s) not approved:       
Attach copies of the disapprovals. 
NOTE:  If this protocol is subsequently rejected or disapproved by another review board, promptly notify UAB 
IRB. 
 
f. Will the protocol be conducted at or recruit participants from the Birmingham Veterans Affairs Medical Center 
(BVAMC)? 
☐Yes ☒No 
If Yes, describe the involvement of the BVAMC:       
Attach the BVAMC consent form(s), if applicable. Attach any other applicable BVAMC forms (such as the 
Privacy and Information Security Checklist and The BVAMC FCOI forms). 
NOTE:  Investigators conducting research at BVAMC must have a BVAMC appointment. 
NOTE:  See the BVAMC section of the IRB Guidebook for more information. 
 
g. Will the protocol be conducted at or recruit participants from the Jefferson County Department of Health 
(JCDH)? 
☐Yes ☒No 
If Yes, describe the involvement of the JCDH and list the JCDH clinics being used:       
Attach the JCDH Research Review Panel approval, if applicable. 
NOTE:  Human subjects research conducted at certain JCDH clinics requires review by the JCDH Research 
Review Panel. See the JCDH section of the IRB Guidebook for more information. 
 
6. Clinical Trial 
Does this protocol meet the following definition of a clinical trial? 
☒Yes ☐No 
*A research study in which one or more human subjects are prospectively assigned to one or more interventions 
(which may include placebo or other control) to evaluate the effects of those interventions on health-related 
biomedical or behavioral outcomes. For more information, see the full definition of clinical trial here. 
If Yes, you will need to fulfill the following requirements (regardless of funding): 
 
a. All key personnel must complete the Good Clinical Practices (GCP) training. For information on this 
requirement, visit the IRB website here. 
 
b. This protocol must be registered on ClinicalTrials.gov. Provide the National Clinical Trial (NCT) identifier 
number: NCT04389970 
If you have any questions regarding registering a study on ClinicalTrials.gov, email the UAB Center for Clinical 
and Translational Science at ccts@uab.edu. 
 
 
7. Multi-Site Studies 

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a. Is this a multi-site study? 
☐Yes ☒No 
b. Is the UAB Investigator the lead investigator?                                                                                       ☐Yes ☒No                   
c. Is this a multi-site study with a coordinating site?  
☐Yes ☒No 
d. Is this a multi-site study with UAB as a coordinating site?                                                                   ☐Yes ☒No 
 
 
If Yes to a, b, c, or d, describe the management of information obtained in multi-site research that might be 
relevant to the protection of participants:       
 
Include, at a minimum, how the following items are managed: IRB approvals from other sites; Unanticipated 
problems involving risks to participants or others. (For example, if there is an unanticipated problem involving 
risks to participants or others, which site is responsible for reporting it?); Interim result; & Protocol 
modifications.             
8. Drugs 
Will any drugs or supplements be used or studied in this protocol? 
☐Yes ☒No 
If Yes, attach the completed Drug Review Sheet. 
If BVAMC, attached the completed BVAMC Drug Review Sheet . 
9. Devices 
a. Will any devices be studied in this protocol? 
☐Yes ☒No 
 
b. Will any not FDA-approved devices be used or studied in this protocol? 
☐Yes ☒No 
If Yes to a or b, attach the completed Device Review Sheet. 
 
10. Special Approvals 
a. Does this protocol involve the use of radioisotopes? 
☐Yes ☒No 
If Yes, attach documentation of approval from the Radiation Safety Division. The protocol has been 
registered with OHS and has now approved the DXA protocol.   
 
b. Does this protocol include patients with contagious infections (e.g., mumps, measles, chickenpox, TB, 
meningitis)? 
☐Yes ☒No 
If Yes, attach documentation of approval from the Infection Control Committee of the appropriate facilities. 
 
c. Does this protocol involve obtaining remnant biopsy or surgical material from the Department of Pathology or 
any other source? 
☐Yes ☒No 
If Yes, attach documentation of approval from the entity or individual providing the materials (e.g., the UAB 
Division of Anatomic Pathology Release of Pathologic Materials). 
 
d. Does this protocol require obtaining any remnant clinical laboratory biospecimens, body fluids, or 
microbiological isolates from the Department of Pathology or any other source? 
☐Yes ☒No 
If Yes, attach documentation of approval from the entity or individual providing the materials (e.g., the UAB 
Division of Laboratory Medicine Release of Pathologic Materials). 
 
e. Does this protocol use stored (existing) biospecimens from a repository? 
☐Yes ☒No 
If Yes, attach documentation of approval for use of biospecimens, and describe how existing biospecimens 
are labeled:       
 
11. Use of Biospecimens 
Does this protocol involve the collection of biospecimens? 
☒Yes ☐No 
If Yes, complete 11.a-11.h. 
If No, skip to Item 12. 
a. How will biospecimens be obtained, processed, distributed, and stored? A fasting blood draw of two (2) 
vials (7 mL or 1.4 teaspoons) via venipuncture (7 mL) will be collected to assess insulin, markers of 
inflammation, and a lipid panel. Serum samples will be stored in the Webb Bldg until the end of the 

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study. Once all data collection is complete, samples will be analyzed by the NORC metabolism core in 
the Webb Bldg. There will be blood collected at baseline and at the follow up visit. 
 
b. How will biospecimens be labeled (e.g., unique identifier, medical record number, Social Security number, 
name, date of birth)? Unique study identifier, date, and assessment point will be the only information 
included on the label. 
 
c. How will clinical data associated with the biospecimens be collected and stored? Clinical data will be stored 
on a password-protected computer on the UAB server. 
 
d. What participant-identifying information will be collected and linked to the biospecimens? Unique study 
identifier will be the only participant-identifying information. 
 
e. What steps will be taken to maximize the confidentiality of linked identifiers? For example, procedures could 
include using a password-protected computer database to link identifiers, with limited personnel 
knowledgeable of the password, or coded identifiers released without the ability to link to clinical data (also 
called “stripped” or “anonymized” biospecimens). Documents connecting the participant with their 
associated identifier will be locked in a cabinet in the Wallace Research Lab and only the PI and 
research coordinator (K. Green) will have access to the files. Also, the information will be available 
through REDCap, which is password protected and only those on this project will have access to the 
information. 
 
f. Is genetic testing planned as part of this protocol? 
☐Yes ☒No 
If Yes, describe the planned genetic testing here.       
i. 
Does this include whole genome sequencing?                                                                        ☐Yes ☐No 
ii. 
Will participants be informed of the results of any DNA testing?                                        ☐Yes ☐No 
 
g. Will biospecimens be stored for future use? 
☐Yes ☒No 
If Yes, indicate whether they will be used for the disease under study in this protocol or research on other 
diseases. In addition, indicate where the biospecimens will be banked       
• If above is a BVAMC location, what IRB is responsible for overseeing the operations of the 
biospecimens bank (i.e., local IRB or other multi-site or central IRB?)       
h. Will biospecimens be shared with other investigators in the future?                                                 ☐Yes ☒No  
i. 
What identifiers, clinical information and demographic information will be shared; or will the 
biospecimens be stripped of identifiers (i.e., anonymized)?       
NOTE: Coding data is not considered anonymous. 
ii. 
Outline your procedure for assuring IRB approval for release and use prior to release of 
biospecimens.       
NOTE:  Investigators who receive and/or use these biospecimens must document approval from the 
appropriate IRB(s) before the biospecimens may be released. 
 
i. Will specimens be destroyed after the project-specific use is completed?                                       ☒Yes ☐No 
j. Will specimens be used and/or shared for commercial profit?                                                           ☐Yes ☒No 
k. Will specimens be destroyed after the project-specific use is completed?                                      ☒Yes ☐No 
       l. Will participants be informed of the results of the specimen testing?                                              ☐Yes ☒No 
       m. Are there any implications for family members based on specimen testing results?                   ☐Yes ☒No 
(If yes, the family members may be participants.)  
 
12. Gene Therapy 
Does this protocol involve gene therapy or administering recombinant materials to humans? 
☐Yes ☒No 

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If Yes, submit the Gene Therapy Project Review Panel Report -OR- the Protocol Oversight Review Form For 
Clinical Vaccine Trials, as applicable. 
 
 
13. HIPAA Privacy and Security 
Will the PI or others obtain, review, or make other use of participants' “protected health information” (i.e., 
information, whether oral or recorded in any form or medium that (a) is created or received by a health care 
provider and (b) relates to past, present, or future physical or mental health or condition of an individual; or 
provision of health care; or payment for provision of heath care)? 
☒Yes ☐No 
If Yes, complete Items 13.a-13.f. 
If No, skip to 14. 
 
a. Will the data/information be stored or managed electronically (on a computer)? 
 
☒Yes ☐No 
 
b. Is the principal investigator requesting that the UAB IRB waive patient HIPAA authorization from another 
institution or entity (e.g., insurance company, collaborating institution)? 
☐Yes ☒No 
If Yes, attach copies of the privacy notices from each institution/entity, and provide the name of each 
institution/entity:       
 
c. Indicate which of the entities would provide health information for this protocol, maintain health information 
as it was collected for this protocol, and/or store health information after it has been collected for this 
protocol. 
☐ UAB Hospital or UAB Hospital - Highlands 
☐ The Kirklin Clinic of UAB Hospital or Acton Road (and/or associated clinics) 
☐ UAB Callahan Eye Hospital 
☐ Children's of Alabama 
☐ Jefferson County Department of Health 
☐ School of Dentistry 
☒ School of Health Professions 
☐ School of Medicine 
☐ School of Nursing 
☐ School of Optometry 
☐ University of Alabama Health Services Foundation 
☐ UAB Health Centers 
☐ Viva Health 
☐ Ophthalmology Services Foundation 
☐ Valley Foundation 
☐ Medical West - UAB Health System Affiliate 
☐ Birmingham Veterans Affairs Medical Center 
☐ None - If None, skip to Item 14. 
 
d. Indicate any information systems that will be the sources of information used for the protocol. 
☐ A system maintained centrally by UAB Health System (these include the following: HealthQuest for 
registration, billing, and patient administration; PowerInsight (clinical data warehouse); Cerner IMPACT 
for PowerNotes for meds, Lab, Radiology, UED, Surgery 
 
NOTE:  If a researcher needs information in a specified format or a specified time, the researcher must 
confirm with the unit who can supply the information/service that the request can be met before writing 

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the information/service into the research protocol. In addition, the researcher must be aware that these 
services may have a cost attached that should be considered in the research budget. 
 
To request access to clinical systems for research purposes, visit 
https://www.oneuabmedicine.org/web/hsis/technical-support, click “Accounts Request” and complete 
the form indicating access for research purposed. 
☐ Another system on a UAB or BVAMC server - Describe: No information systems will be the sources of 
information for the protocol.  
 
e. Indicate which of the listed identifiers will be accessed, associated and/or linked with the protected health 
information (PHI) used for this protocol. 
☒ Names 
☒ Geographic subdivisions smaller than a state 
☒ Elements of dates (except year) related to an individual 
☒ Telephone numbers 
☐ Fax numbers 
☒ Email addresses 
☒ Social security numbers 
☐ Medical record numbers 
☐ Health plan beneficiary numbers 
☐ Account numbers 
☐ Certificate/license numbers 
☐ Vehicle identifiers and serial numbers 
☐ Device identifiers and serial numbers 
☐ Biometric identifiers 
☐ Web universal resource locators (URLs) 
☐ Internet protocol address numbers 
☐ Full-face photographic images 
☐ Any other unique identifying number - Describe:       
NOTE:  Codes are not identifying as long as the researcher cannot link the data to an individual 
☐ None - If None, skip to Item 14. 
 
f. Choose one plan to describe your use of the personal health information: 
☐ The data collected meet the specifications for a “limited data set” (LDS) 
-If the LDS will leave the covered entity or will be received from another covered entity you will need a 
Data Use Agreement 
 
☒ Research staff will obtain authorization from each participant to use the information 
-Include the HIPAA Authorization form, complete except for participant name and IRB protocol number, 
as the final page of the consent form 
 
☐ PI requests waiver of authorization to use the information 
-Attach Waiver of Authorization and Informed Consent form 
NOTE: For BVAMC research, the BVAMC HIPAA authorization form or UAB HIPAA waiver form must be 
completed and submitted with the HSP. 
 
PROPOSED RESEARCH 
• The IRB will not accept grant applications and/or sponsor's protocols in lieu of the items as outlined below. 
• Do not separate responses from items. Instead, insert your response to each item below the item, keeping the 
information in the order of this form. 
 

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14. Purpose - in nontechnical, lay language 
a. Summarize the purpose and objectives of this protocol in one short paragraph.  
 
The purpose of this pilot study is to determine the preliminary efficacy, safety, and acceptability of 
time restricted feeding (TRF) among a sample of 12 adults with Relapsing-Remitting Multiple Sclerosis 
(RRMS). The specific aims of this study are: 1: To determine preliminary efficacy of TRF for reducing 
symptom burden, improving inflammatory markers, and reducing cardiometabolic risk among adults 
with RRMS. 2: To determine the safety and participant acceptability of TRF. Participants will be asked 
to consume all food during an 8-hour window each day and not eat for the remaining 16 hours.  All 
participants will follow this eating pattern for 8 weeks.  
 
b. Describe how outcomes will be measured for this protocol.  
I. Clinical outcomes of MS. We will use the Multiple Sclerosis Functional Composite (MSFC) and the 
Patient-Determined Disease Steps (PDDS) to measure clinical outcomes. The MSFC includes three 
components: a timed 25-foot walk, 9-hole peg test, and the symbol digit modalities test. The PDDS is a 
patient-reported measure of disability.  
 
II. Patient-reported outcomes. Symptoms of depression, anxiety, fatigue, and pain will be measured by 
the Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS), Fatigue 
Severity Scale (FSS), and short-form McGill Pain Questionnaire (SF-MPQ), respectively. We will 
measure sleep using the Pittsburg Sleep Quality Index. The HADS contains 14 items that measure the 
frequency of anxiety and depressive symptoms over the past week. The MFIS is a 21-item measure of 
physical, cognitive, and psychosocial impact of fatigue on daily life over the past 4 weeks. The FSS is a 
9-item unidimensional measure of fatigue and its disabling consequences over the past week in medical 
populations including MS. The Fatigue Severity Scale is scored on a 7-point Likert scale, where 1 means 
strongly disagree and 7 means strongly agree. All items refer to the physical domain of fatigue, meaning it 
measures the effects of fatigue on a person’s activities and lifestyle. The SF-MPQ has a 15-item adjective 
checklist that captures sensory and affective dimensions of pain experienced over the past week. 
Participants will also be asked to record levels of hunger, fatigue, sleep quality and energy on a daily 
basis via the food journaling app used to record dietary intake.  
 
III. Cardiometabolic risks. We will measure cardiometabolic risks by anthropometrics (height, weight, 
and waist circumference), body composition, blood pressure, and lipid panel, fasting insulin. 
 
IV. Biomarkers of inflammation will include TNF-α, IL-6 and IL-17.  
   
V. Participant acceptability will be measured by self-report questionnaire at midpoint (4 weeks) and 
end point (8 week).  
 
15. Background - in nontechnical, lay language 
Summarize in 2-3 paragraphs past experimental and/or clinical findings leading to the design of this protocol. 
Include any relevant past or current research by the PI. For drug and device studies, summarize the previous 
results (i.e., Phase I/II or III studies). 
 Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disease of the central 
nervous system. The disease manifests as symptoms (e.g. fatigue and depression) and impairments (e.g. 
walking and cognition) that compromise quality of life and participation. Over the last decade there has 
been an influx of evidence demonstrating the impact of lifestyle risk factors including physical inactivity, 
smoking, and poor diet on the progression of MS symptoms. Specifically, epidemiological studies 
consistently report that poor diet is associated with increased risk of disability in adults with MS. Diet may 
impact risk of disability by directly complicating the disease process through exacerbating inflammation or 

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impairing immune responses. It may also have an indirect impact by increasing risk for vascular and 
cardiometabolic diseases, which are common among adults with MS and are associated with worse 
prognosis of MS. Despite the evidence of the association between poor diet and MS, little research has 
explored dietary interventions that may reduce symptom burden of MS, or the mechanisms through which 
these interventions may work.  
One dietary intervention that has shown particular promise in animal models of MS is intermittent 
fasting (IF), which is a dietary pattern characterized by cycles of eating and extended fasting (see attached 
for animal model literature). There are a number of protocols for IF, the most popular of which include 
alternate day modified fasting (cycling between days of substantially restricted caloric intake and days of 
unrestricted eating); and time restricted feeding (TRF), in which all food is consumed during a limited 
window of time each day (typically less than 10-12 hours). There is growing evidence that demonstrates IF 
reduces inflammation, improves immune function and improves cardiometabolic risk in animal models of 
MS, however, very little of this research has been translated into human trials of MS. In addition to the 
physiological benefits, we also believe that IF, and particularly TRF, will provide a behavioral benefit, as it 
addresses many of the barriers traditionally seen in dietary interventions by shifting the focus from 
restricting what participants can eat, to only focusing on meal timing.  
An eight-hour eating window was chosen for this trial in an effort to balance efficacy with feasibility. 
TRF protocols of 4 and 6 hour eating windows have been tested without major adverse events, however this 
may be too short of a window for people to realistically stick with. Conversely, The median American eats 
over a 12.4-hour period, so using a longer window such as 10 hours may not confer as many benefits from a 
modest change. Safety and efficacy of an 8-hour window has been published in other populations 
(references attached).  
 
16. Participants (Screening and Selection) 
a. How many participants are to be enrolled at UAB (if other sites relying on UAB IRB, list the number for each 
site)? 12 
If multi-site study, total number at all sites/institutions:       
 
b. Describe the characteristics of anticipated or planned participants (if multiple groups, repeat list for each 
group). 
Sex: Male and Female 
Race/Ethnicity: All races/ethnic groups will be recruited 
Age: 18-65 
Health status: Diagnosis of relapsing-remitting MS; stable on current disease modifying treatment (or 
not on treatment) for 6 months; no relapse within previous 30 days. 
 
c. From what population(s) will the participants be derived? We will recruit participants through flyers posted 
at Lakeshore Foundation, UAB Neurology clinics, and the UAB MS Center, as well as direct mail to 
Lakeshore Foundation members who have noted interested in participating in research.  
 
Describe your ability to obtain access to the proposed population that will allow recruitment of the 
necessary number of participants: Dr. Wingo is actively involved with the UAB/Lakeshore Research 
Collaboration and has access to study participants from the Lakeshore Foundation. Lakeshore has over 
5000 active and inactive members with disabilities. She also collaborates with physicians and research 
staff at the UAB Neurology clinics and MS center. Dr. Rinker will also inform potential patients who 
are treated in the MS clinics about the study. 
 
d. Describe the inclusion/exclusion criteria:  
 
Inclusion Criteria:  
1. 18-65 years old 
2. Diagnosed with Relapsing-Remitting MS 
3. If on disease-modifying medications, stable for 6 months. 

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4. If not on disease-modifying medication, no medication usage within previous 6 months.  
5. BMI 18.5-50 kg/m2 
6. Able to walk 25 ft. with or without assistance 
 
Exclusion Criteria:  
1. Relapse within previous 30 days 
2. Actively engaged in a weight loss program or unwilling to follow assigned dietary timing pattern 
3. Regularly fasts >15 hours/day 
4. Pregnant or breastfeeding 
5. Current use of insulin or sulfonylurea agents 
6. Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status 
assessment 
 
e. If participants will comprise more than one group or stratification, describe each group (e.g., 
treatment/intervention, placebo, controls, sham treatment) and provide the number of participants 
anticipated in each group. NA 
 
f. Indicate which, if any, of the special populations listed below will be involved in the protocol. Include the 
Special Populations Review Form (SPRF) if indicated. 
☐ Pregnant Women: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Fetuses: Attach SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Neonates/Nonviable Neonates: SPRF—Pregnant Women, Fetuses, Neonates/Nonviable Neonates 
☐ Prisoners: Attach SPRF—Prisoners 
☐ Minors (<18 years old): Attach SPRF—Minors NOTE: For BVAMC Research <19 years old 
☒ Employees or students at institution where research conducted 
☐ Persons who are temporarily decisionally impaired 
☐ Persons who are permanently decisionally impaired 
☐ Non-English Speakers 
For each box checked, describe why the group is included and the additional protections provided to protect 
the rights and welfare of these participants who are vulnerable to coercion: Adults with MS who are  
employees  or  students  of  UAB  or  Lakeshore  Foundation  may  participate  in  this  study.  
Participation for all study participants will be on a voluntary basis.  Participants will be assured that  
all  responses  will  be  kept  confidential  and  that  participation  will  not  be  shared  with  their 
supervisor. Participants will not be anyone who is under the supervision of Dr. Wingo at UAB or 
Lakeshore.   
 
g. List any persons other than those directly involved in the protocol who will be at risk. If none, enter “None”: 
None 
 
h. Describe the recruitment process (e.g., medical record review, referrals, letter of invitation, existing patients) 
that will be used to seek potential participants (e.g., individuals, records, specimens). Research recruitment 
by non-treating physicians/staff may require completion of Partial Waiver of Authorization for 
Recruitment/Screening. Flyers will be posted in common areas around Lakeshore Foundation, UAB 
Neurology Clinic, and MS Center (see attached for flyer). The same flyers will be included in 
newsletters emailed and/or mailed to Lakeshore Foundation members. Lakeshore  Foundation also  
maintains a database  of members  who  are  interested  in  participating  in  research and  this  
database  will  be  used  for targeted recruitment.  Lakeshore members are also aware of ongoing 
research and are welcome to visit the research office and lab at any time. Members who present to the 
research office and inquire about research opportunities will be made aware of the study. 
 

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i. If you will use recruitment materials (e.g., advertisements, flyers, letters) to reach potential participants, attach 
a copy of each item. If not, identify the source (e.g., IRB Protocol Number for approved databases) from 
which you will recruit participants. See attached. 
 
j. Describe the screening process/procedures for potential participants. Participants will call the phone 
number listed on the study flyer or come by the research office to inquire about research possibilities.  
Study staff will give potential participants additional information about the study using attached script.  
If the person is interested in participating, the staff will ask a series of questions to assess eligibility.  
This will include age, self-reports of height and weight, disease-modifying medication use, dietary 
habits, cognitive screening (utilizing the Telephone Interview for Cognitive Status (TICS-m)), as well as 
primary mode of ambulation. If potential participant meets eligibility criteria, he/she will be scheduled 
for baseline data collection. Pregnant women will be excluded because it is not safe for them to have a 
DXA scan.  Women who are currently breastfeeding will be excluded due to hormone differences and 
fluctuations which can impact diet. These impacts could skew results on metabolic outcomes of the diet.  
 
17. Protocol Procedures, Methods, and Duration - in nontechnical, lay language 
a. Describe the procedures for all aspects of your protocol. Tell us what you are doing. Twelve adults 
with relapsing-remitting multiple sclerosis (RRMS) will be recruited. Participants will take part in an 8-
week trial in which they will eat all food during an 8-hour window each day. They will be asked to 
consume only water, unsweetened tea, or black coffee during the remaining 16 hours of each day. 
 
At the baseline visit, study staff will administer and review the consent forms with the participant and 
the participant will sign them before any data collection or intervention begins. After signing the 
consent forms, all baseline measures will be collected. Baseline measures include: 
1. Anthropometric measures: Waist circumference will be measured twice al at the level of the umbilicus 
after normal expiration, with participants standing. If the two values differ by >1 cm, a third 
measurement will be taken and the results of the two or three trials averaged. Height will be measured 
with participants standing against the wall. Weight will be assessed using a digital scale. BMI will be 
calculated using the formula weight/height2 (kg/m2).  Blood pressure will be obtained and participants 
will also be asked to inform study staff of all current medications and supplements being taken. 
2. Blood work: Fasting insulin, lipid panel, TNF-α, IL-6 and IL-17 will be collected on all participants. 
Two (2) vials of blood will be drawn (7 mL or 1.4 teaspoons) via venipuncture. 
3. DXA: Total and regional body composition will be measured on a Lunar Prodigy with enCORE 
software version 13.6 (GE Healthcare, Chicago, IL). Participants will undergo a total body scan 
requiring about 20 minutes, while lying on their back on a padded table with metal objects removed. 
The scan provides estimates of soft tissue attenuation ratios, fat and lean tissue mass, and bone 
mineral density. Individuals who are too large to scan in a single scan will be scanned twice (one 
scan for the left half of body, one for the right).  The software is able to merge the two scans to assess 
total body composition. All women of child-bearing age will be required to complete a pregnancy 
test in the lab prior to DXA scan.  
4. Patient-reported outcomes: Participants will complete the following questionnaires: Demographics, 
Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS), Fatigue 
Severity Scale (FSS), short-form McGill Pain Questionnaire (SF-MPQ), and Pittsburg Sleep Quality 
Index. Copies of each are attached.  
5. Accelerometer: Participants will wear an Actigraph accelerometer Version 6.13.3 on the waist for 7 
days. We will classify activity counts into sedentary behavior, light, moderate and vigorous activity. 
We will record total minutes of activity in each category.  
6. Dietary adherence: The UAB CCTS will perform three 24 hour dietary phone recalls with each 
participant over a 14 day period. These calls will be unannounced and participants will be informed 
that they will be asked to recall all they consumed within the last 24 hours at the time of the call.  
They will receive two of the three recall phone calls during the week, and one on a Monday morning 
to capture a weekend recall. CCTS staff will follow standard protocols for performing a 24 hour 

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food recall and study staff will provide participants with materials at baseline to help them answer 
the food recall questions. Participants will receive three more 24 hour dietary recall phone calls at 
the 8 week mark. 
7. Timed 25-Foot Walk (T25-FW): The T25-FW is a quantitative mobility and leg function 
performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly 
marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is 
calculated from the initiation of the instruction to start and ends when the participant has reached 
the 25-foot mark. The task is immediately administered again by having the participant walk back 
the same distance. Participants may use assistive devices when doing this task. Assistive devices may 
include braces, a cane, or a walker. 
8. 9-Hole Peg Test (9-HPT): The 9-HPT is a brief, standardized, quantitative test of upper extremity 
function. Both the dominant and non-dominant hands are tested twice. The participant is seated at a 
table with a small, shallow container holding nine pegs and a wood or plastic block containing nine 
empty holes. On a start command when a stopwatch is started, the participant picks up the nine 
pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, 
removes them again as quickly as possible one at a time, replacing them into the shallow container. 
The total time to complete the task is recorded. Two consecutive trials with the dominant hand are 
immediately followed by two consecutive trials with the non-dominant hand. 
9. Symbol Digit Modalities Test (SDMT): The SDMT is a five-minute assessment that quickly screens 
the participant for any kind of cerebral dysfunction using a simple substitution task. When 
undertaking the SDMT, a participant is given a reference key that they must use to help them 
connect basic Arabic numerals (1-9) to a series of geometric shapes (i.e. reference key= key showing 
which number aligns with each symbol). Responses can be verbal or written, and the entire test 
should be finished in 90 seconds. Scoring and evaluation of the test takes a further five minutes to 
complete. Because responses can be written or spoken, it can be used with a broad spectrum of 
participants, including those suffering from motor disabilities and speech impediments.  
10. Patient-determined disease steps (PDDS): The PDDS is a patient-reported measure of disability.  
11. Participant Satisfaction with the meal timing plan will be measured by questionnaire (see attached).  
 
At the end of the baseline visit, the research coordinator will give the participant an accelerometer to 
wear around their waist for 7 days, along with a stamped envelope to return the accelerometer at the end of 
the week. She will also provide detailed instructions on the 24 hour food recalls that will be conducted over 
the next 14 days. The baseline visit is about 2 hours. The coordinator will explain the meal timing protocol 
in detail, introduce them to the food journaling app that will be used to record food intake and daily 
symptoms, and answer any questions the participant may have. Finally, the coordinator will schedule a 
time for the first weekly check in call.  
 
Participants will be instructed to eat all meals in an 8 hour window. Participants will be allowed to choose 
the times in which they eat in an effort to maximize adherence, but must start no later than 11:00 am (e.g. 
participants who typically wake early may choose to eat from 8:00 am- 4:00 pm, while those who typically 
eat later in the day may choose to eat from 11:00 am- 7:00 pm). During the 16-hour fasting period, 
participants will be instructed to drink only water, unsweetened tea, or black coffee, and not eat any food. 
Participants will be provided with an electronic food journal (HealthWatch 360), and instructed to record 
all food and beverages consumed daily, along with the time of day consumed. The HealthWatch 360 
platform includes a HIPAA-compliant research portal, which allows the research staff to view participants’ 
entries in real-time. It is accessible via a mobile app and desktop version, so participants have multiple 
ways to enter data depending on their preference.  
 
Participants will receive daily caloric prescription intended to maintain baseline weight (i.e. an isocaloric 
diet based on Harris-Benedict estimation equation), but will not have any other restriction on intake. This 
will allow for analysis of the impact of food timing independent of calorie restriction or weight loss.  

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All participants will receive weekly calls from the study coordinator. During these calls, the coordinator will 
review food records with the participant, conduct weekly adverse event screening, and answer any 
questions from the participants. She will also help participants who are having trouble adhering to the 
prescribed feeding plan problem solve ways to increase adherence. 
 
At the mid-point of the study (4 weeks) participants will be sent a link to a REDCap survey to complete the 
mid-point participant satisfaction survey. They will not need to come to the lab to complete this. If they do 
not have access to the internet, we will mail a hard copy along with a stamped/addressed return envelope 
for them to return the survey.  
 
After 8 weeks, participants will return to the Wallace research lab to repeat the same data collection 
protocol as they did at baseline, with the exception of PDDS, which will only be completed at baseline. 
 
b. What is the probable length of time required for the entire protocol (i.e., recruitment through data analysis to 
study closure)? 12 months 
 
c. What is the total amount of time each participant will be involved? 12 weeks (2 week baseline measures, 8 
weeks intervention, 2 week follow-up measures). 
 
d. If different phases are involved, what is the duration of each phase in which the participants will be involved? 
If no phases are involved, enter “None.” None 
 
e. List the procedures, the length of time the procedure takes, the total # of times the procedure is performed, 
and indicate whether each is performed solely for research or would already be performed for treatment or 
diagnostic purposes (routine care) for the population. 
-Insert additional table rows as needed. 
-If procedure is sometimes research and sometimes routine care, include on separate lines with number of 
times as each. 
 
Procedure 
Length of Time Required 
of Participants 
Total # of Times the 
Procedure is Performed 
Research (Res) –OR- Routine Care  
Anthropometrics 
15 minutes 
Baseline and follow up 
☒Res  ☐Routine 
Bloodwork  
10 minutes 
Baseline and follow up 
☒Res  ☐Routine 
DXA 
20 minutes 
Baseline and follow up 
☒Res  ☐Routine 
Questionnaires 
~30 minutes 
Baseline and follow up 
☒Res  ☐Routine 
Timed 25-Foot 
Walk (T25-FW) 
1-5 minutes 
Baseline and follow up 
☒Res  ☐Routine 
9-Hole Peg Test 
(9-HPT) 
10 minutes or less 
Baseline and follow up 
☒Res  ☐Routine 
Symbol Digit 
Modalities Test 
(SDMT) 
5 minutes 
Baseline and follow up 
☒Res  ☐Routine 
Patient-
Determined 
Disease Steps 
(PDDS) 
20 minutes 
Baseline 
☒Res  ☐Routine 

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24 Hour Glucose 
Monitoring 
24 hours 
Baseline and follow up 
☒Res  ☐Routine 
24 Hour Dietary 
Recall 
3 days 
Baseline and follow up 
☒Res  ☐Routine 
Accelerometer 
7 days 
Baseline and follow up 
☒Res  ☐Routine 
Participant 
Satisfaction 
Survey 
15 minutes 
Midpoint, follow up 
☒Res  ☐Routine 
Dietary 
intervention 
8 weeks 
One time only 
☒Res  ☐Routine 
Symptom Rating 
2 minutes 
Daily during 
intervention  
☒Res  ☐Routine 
 
f. Will an interview script or questionnaire be used? 
☒Yes ☐No 
If Yes, attach a copy. 
 
g. Will participants incur any costs as a result of their participation? 
☐Yes ☒No 
If Yes, describe the reason for and amount of each foreseeable cost.       
 
h. Will participants be compensated? 
☒Yes ☐No 
If Yes, complete i-v. 
i. Type: (e.g., cash, check, gift card, merchandise): Check 
ii. Amount or Value: $100 
iii. Method (e.g., mail, at visit): Mail 
iv. Timing of Payments: (e.g., every visit, each month): $50 at completion of baseline measures, $50 at 
completion of study. 
v. Maximum Amount of Compensation per Participant: $100 
 
18. Benefits 
Describe the potential benefits of the research. The potential benefit of this study is that individuals with 
RRMS may have improved health (cardiometabolic risk reduction) and reduced symptoms of RRMS (pain, 
fatigue). There is also a potential that we will learn more about the way TRF impacts RRMS, which will 
allow more information on which to base future larger trials.  
 
19. Risks - in nontechnical, lay language 
a. List the known risks for participants as a result of participation in the research. This should not include the 
minimal risk of loss of confidentiality. However, it should include any physical, psychological, social, 
economic, and/or legal risks. If there is a greater than minimal risk of loss of confidentiality describe why this 
is so. Do not list risks associated with the standard-of-care procedures. 
NOTE:  Risks included here should be included in the consent form or information sheet, as applicable. 
1. Fasting prior to bloodwork: Participants may experience a drop in blood sugar causing 
lightheadedness, dizziness, nausea, sweating, and shakiness as a result of fasting before their baseline 
and follow up visits. 
 
2. Blood draw: Participants may experience pain and/or bruising during venipuncture. 
 
3. 24 hour glucose monitor: Participants may experience discomfort, pain, swelling, and bruising from the 
needle insertion and also a chance of skin irritation from the adhesive. In rare cases, the sensor may 
fracture, or the insertion site may become infected.   
 

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4. DXA: A DXA scan is an x-ray scan that uses a very low-level of radiation. The radiation dose received 
from the 1 to 2 scans is equivalent to about 8 days natural background radiation. Background radiation 
is radiation normally received from sources such as cosmic rays and natural radioactivity in building 
materials and the ground. A small risk of cancer and other radiation effects, which may not be known 
at this time, may develop from each scan you receive. 
 
5. Loss of confidentiality: The potential risk to subjects involves loss of confidentiality regarding exposure 
to information obtained through a secure internet website, although our hosting environment is HIPAA 
compliant. 
 
6.  There is the possibility that MS could get worse over the duration of the study.  
 
 
b. Estimate the frequency, severity, and reversibility of each risk listed.  
1. Fasting prior to bloodwork: Risks associated with fasting are typically rapidly reversible upon ingesting 
food and drink or lying down and should not result in severe harm to the participant. 
 
2. Blood draw: Discomfort associated with venipuncture is rapidly reversible. Bruises from venipuncture 
will heal in several days. 
 
3. 24 hour glucose monitor: All the expected risks are minimal, mild in severity, and expected to be 
reversible. 
 
4. Loss of Confidentiality: We expect the potential loss of confidentiality to be low given the security and 
privacy provisions at the Wallace research lab.   
 
 
c. Is this a therapeutic study or intervention? 
☐Yes ☒No 
If Yes, complete i.-iii. 
i. Describe the standard of care in the setting where the research will be conducted:       
ii. Describe any other alternative treatments or interventions:       
iii. Describe any withholding of, delay in, or washout period for standard of care or alternative treatment 
that participants may be currently using:       
 
d. Do you foresee that participants might need additional medical or psychological resources as a result of the 
research procedures/interventions? 
☐Yes ☒No 
If Yes, describe the provisions that have been made to make these resources available.       
 
e. Do the benefits or knowledge to be gained outweigh the risks to participants? 
                    ☒Yes ☐No 
If No, provide justification for performing the research:       
 
20. Precautions/Minimization of Risks 
a. Describe precautions that will be taken to avoid risks and the means for monitoring to detect risks.  
Data Security: All data will be entered into RERCap, and stored on the UAB REDCap secure server. 
Only Dr. Wingo and the study coordinator will have access to download the data from REDCap.  
 
The intervention and measurement protocols pose minimal risk to participants. Participants will be asked 
a set of questions each week to assess their general health (see attached Adverse Event form).  If a 
participant reports any notable changes for 2 consecutive weeks, that information will be given to Dr. 
Rinker for review. 
 

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Any serious adverse events will be promptly reported to the Institutional Review Board at UAB. Safety 
reports will be sent to the PI from the intervention staff, or data collection staff if the event occurs during 
baseline/follow up testing. The PI will be responsible for reviewing the data with Dr. Rinker. The adverse 
event weekly check and referral to Dr. Rinker is the safety plan.  
 
 
If the protocol involves drugs or devices skip Items 20.b. and 20.c. and go to Item 21. Instead, include this 
information in the Drug Review Sheet or Device Review Sheet, as applicable. 
 
 
b. If hazards occur to an individual participant, describe (i) the criteria that will be used to decide whether that 
participant should be removed from the protocol; (ii) the procedure for removing such participants when 
necessary to protect their rights and welfare; and (iii) any special procedures, precautions, or follow-up that 
will be used to ensure the safety of other currently enrolled participants. The PI will monitor protocol 
adherence. Throughout the study, study staff will inform the PI of adverse events. Events determined by 
the PI and Dr. Rinker to be unanticipated serious problems involving risks to subjects will be reported 
by the PI to the IRB and the directors of the UAB NORC Pilot and Feasibility Grant Program, within 5 
working days of becoming aware of the event. Non-serious adverse events will be reported per IRB 
policy at the time of continuing review. If any protocol changes are needed as a result of an adverse 
event, the PI will submit a modification request to the IRB. Protocol changes will not be implemented 
prior to IRB approval.   
 
c. If hazards occur that might make the risks of participation outweigh the benefits for all participants, describe 
(i) the criteria that will be used to stop or end the entire protocol and (ii) any special procedures, precautions, 
or follow-up that will be used to ensure the safety of currently enrolled participants. If the risks involved in 
participating appear to exceed the benefits during review of occurrences of serious adverse events, the PI 
will consult with the complete investigator team, as well as the directors of the NORC Pilot and Feasibility 
Grant program to decide to terminate the study. If the study is terminated, participants will be given 
information related to the study risks that may have affected them or their health.   
 
21. Informed Consent 
a. Do you plan to obtain informed consent for this protocol? 
☒Yes ☐No 
If Yes, complete the items below. 
If No, complete and include the Waiver of Informed Consent or Waiver of Authorization and Informed 
Consent, as applicable. 
*For research being conducted at the BVAMC, the UAB Consent waiver form must be completed and 
submitted with the HSP. 
 
b. Do you plan to document informed consent (obtain signatures) for this protocol? 
☒Yes ☐No 
If Yes, complete the items below. 
If No, complete the items below and include the Waiver of Informed Consent Documentation. 
 
c. How will consent be obtained? When a potential participant is interested in the study, the study 
coordinator will provide a detailed description of the study, screen the participant for eligibility, answer 
any questions, and if appropriate, schedule their first visit. At the beginning of the first visit, consent will be 
obtained prior to any testing. The consent will be completed in duplicate so that subjects can retain one 
copy of the document.  
 
d. Who will conduct the consent interview? The research coordinator 
 
e. Who are the persons who will provide consent, permission, and/or assent? The participant 
 
f. What steps will be taken to minimize the possibility of coercion or undue influence? Participants will be self-
referred. As described above, the consent form will be carefully reviewed with participants. Further, they 
will have at least 24 hours to consider participation in the study. 

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g. What language will the prospective participant and the legally authorized representative understand? English 
 
h. What language will be used to obtain consent? English 
 
i. If any potential participants will be, or will have been, in a stressful, painful, or drugged condition before or 
during the consent process, describe the precautions proposed to overcome the effect of the condition on 
the consent process. If not, enter “None.” None 
 
j. If any protocol-specific instruments will be used in the consenting process, such as supplemental  handouts, 
videos, or websites,  describe these here and provide a copy of each. If not, enter “None.” None 
 
k. How long will participants have between the time they are told about the protocol and the time they must 
decide whether to enroll? If not 24 hours or more, describe the proposed time interval and why the 24-hour 
minimum is neither feasible nor practical. 24 hours or more 
 
22. Procedures to Protect Privacy 
Describe how you will protect the privacy interest of the participants. Include how you will make sure others 
cannot overhear your conversation with potential participants and that individuals will not be publicly identified 
or embarrassed. Any interested individuals who are screened for eligibility in person, will be screened in a 
private room one-on-one.  Consent will be obtained in a quiet space, and all assessments will only involve 
the necessary staff needed to perform the testing.  Furthermore, all weekly participant phone calls will be 
performed in privacy behind closed doors. 
 
23. Procedures to Maintain Confidentiality 
a. Describe how you will store research data to maintain confidentiality (both paper records and electronic 
data), including how access is limited. If data will be stored electronically anywhere other than a server 
maintained centrally by UAB, identify the department and all computer systems used to store protocol-related 
data. All pre and post-test data will be entered into a secure server maintained by UAB (REDCap).  
 
Participants will be assigned a unique identification code. The file including subjects’ identification and 
code numbers will be kept in the REDCap study database. Any paper with identifying information will 
be destroyed at the earliest possible time following completion of the study. All data will be analyzed 
according to group information, with no possibility of disclosing individual subject identity. All 
publications and presentations of the findings of the study will not contain personal, identifying 
information of study subjects. 
 
Emails will be used to send appointment reminders. Emails will not contain any PHI, they will only 
include appointment reminders. Emails will only be sent from Dr. Wingo’s lab email address 
(hbdlab@uabmc.edu). All participants will consent to using email as a form of communication. There 
will also be a disclaimer at the end of all the emails stating that they are unencrypted emails.   
 
b. Will any data from this protocol be given to any person, including the subject, or any group, including 
coordinating centers and sponsors? 
☒Yes ☐No 
If Yes, complete i-iii. 
i. Who will receive the data? The funding agency- Nutrition Obesity Research Center 
ii. What data will be shared? Aggregate data on baseline characteristics and outcomes of the sample will 
be reported. 
iii. How will the data be identified, coded, etc.? No identifiable or individual-level data will be given. 
 
24. Genomic Data Sharing (GDS) 

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Researchers who collect genomic data as part of a NIH grant funded after January 25, 2008 may be required to 
submit those data to a NIH database for broad scientific sharing. See Genomic Data Sharing in the IRB Guidebook 
for more information. 
 
a. Does this protocol involve the proposed submission of genetic data into genomic repositories created to share 
genetic information for research purposes? 
☐Yes ☒No 
 
b. Will UAB be uploading the final genomic data to the central repository (e.g., dbGaP)? 
☐Yes ☒No 
If Yes to both a and b, submit a Detailed Data Sharing Plan to the IRB for review. This plan should include any 
known data use limitations and indicate whether aggregate-level data are appropriate for general research 
use. For guidance see the NIH Genomic Data Sharing Policy. 
 
c. Submit a copy of the NIH Institutional Certification Form. 
To determine which certification form to include, answer i-ii. 
i. Was this protocol funded prior to January 25, 2015? 
☐Yes ☐No 
• If yes, and consent will be obtained, submit the Extramural Institutional Certification - Before January 
25 - With Consent. 
• If yes, and consent will not be obtained, submit the Extramural Institutional Certification - Before 
January 25 - Without Consent. 
ii. Was this protocol funded after January 25, 2015? 
☐Yes ☐No 
• If yes, submit the Extramural Institutional Certification - After January 25. 
 
25. Additional Information 
In the space below, provide any additional information that you believe may help the IRB review the proposed 
research, or enter “None.” None 
 
 

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Sample size and statistical analysis plan 
The goals of this study were to determine the feasibility of TRE and to collect exploratory pilot data. A sample 
of n = 10−12 per group has been reported to be adequate for a pilot study when there are no existing data available. 
Given the lack of previous data on TRE in adults with MS, a sample size of n = 12 was determined to be adequate. 
An a priori cut point for feasibility was set at 80% of participants completing all pre- and post-intervention measures. 
 
Feasibility variables were assessed with descriptive statistics, specifically frequency and mean and standard 
deviation. Secondary outcomes were explored descriptively and with single-group paired samples t-tests. 
Significance values are presented, and results are highlighted whenever either the changes were clinically 
meaningful and/or p<.20, a standard threshold used for pilot studies; however, due to the exploratory nature of these 
analyses, the study was not powered to find significance among changes in these variables. Cohen’s d was 
calculated to determine the effect size of changes between baseline and follow-up. Given the small sample and 
exploratory nature of the study, all paired-samples analyses included only those participants who completed the 
study. All statistical analyses were conducted with SPSS v 27 (IBM Corporation; Armonk, NY). 
 

Page 1 of 9
Version Date: 7/13/2020
CONSENT FORM
Title of Research:
Time Restricted Eating Outcomes in Multiple Sclerosis (TREO_MS)
UAB IRB Protocol #:
IRB-300005334
Principal Investigator:
Brooks C. Wingo, Ph.D.
Sponsor:
UAB Nutrition Obesity Research Center
General Information
You are being asked to take part in a research study. This research study is 
voluntary, meaning you do not have to take part in it. The procedures, risks, 
and benefits are fully described further in the consent form.
Purpose
The purpose of the study is to test the initial effects, safety, and acceptability 
of time-restricted eating in adults with Relapsing-Remitting Multiple 
Sclerosis (MS). 
Duration & Visits
You will come to the UAB Wallace Research Lab on the Lakeshore 
Foundation campus a total of two times over a 12 week time period (one 
time at the start of the study and one time at the end) The visit at the start, 
and the visit at the end will last about 2 hours.
Overview of Procedures
You will come to a beginning visit that includes a physical exam, blood draw, 
physical and cognitive assessments measuring the disability and symptoms 
of MS, and completion of surveys related to symptoms of MS. For two weeks 
after the first visit, you will wear an activity monitor on your waist and 
complete 3 food recalls with a registered dietitian. Once you have completed 
the two weeks of testing, you will follow the study diet for 8 weeks. The 
study diet entails eating all of your meals within an 8 hour period each day. 
You will have access to a food journaling app to record all your food intake, 
and the time of your first and last meal each day.  You will also receive a call 
from the study dietician each week. You will come back to Wallace Research 
Lab after completing the 8-week program to complete the same testing you 
completed at the beginning.
Risks
The most common risks include dizziness or lightheadedness while fasting 
for testing, pain or bruising from the blood draw, and loss of confidentiality. 
Additionally, a small risk of cancer and other radiation effects, which may 
not be known at this time, may develop from each DXA scan you receive. 
Some people also report hunger and fatigue when starting a new diet 
pattern, however these typically resolve after a few days.  
Benefits
You may or may not benefit from participating in this study.
Alternatives
If you do not want to take part in the study, the alternative is to not 
participate in this study.
Purpose of the Research
We are asking you to take part in a research study. The purpose of this research study is to test 
if the time of day that you eat impacts symptoms of MS such as pain and fatigue, clinical 
UAB IRB
Approved
20-Sep-2020
until
18-Aug-2021

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outcomes of MS such as hand/leg function and cognition, and risk for diabetes and heart 
disease. 
People who enter the study will eat all of their food over an 8 hour window each day. This is a 
pilot study, and this is the first study of daily meal timing patterns in people with MS. In 
addition to the effect of meal timing, we are also testing for safety of this eating pattern, and 
how well people tolerate and enjoy the pattern. There will be 12 participants enrolled in this 
study.
Explanation of Procedures
Before you can begin the intervention, you will complete baseline assessments at the UAB 
Wallace Research Lab at Lakeshore Foundation.  The visit will take approximately 2 hours.
Baseline Visit 1: During this visit, we will measure your height, weight, waist circumference, and 
blood pressure.  We will also measure body composition and collect blood work using tests 
explained below. 

Blood Work – We will draw 2 vials of blood (7 mL or 1.4 teaspoons) via venipuncture to 
measure your insulin, and lipids (cholesterol and triglyceride levels), as well as markers of 
inflammation (TNFα, IL-6, IL-17). You will be asked to not eat or drink anything after 12:00 
am the morning of your blood draw.

Body Composition – We will measure your body composition (body fat percentage, fat 
mass and muscle mass) using a DXA scan. The DXA uses very low level radiation to measure 
your total body composition including fat mass and bone density. To complete the DXA, you 
will lie on a table and a machine will pass over your body. Prior to completing the scan, all 
women of child bearing potential will undergo a urine pregnancy test to ensure that there is 
no risk of undue harm to the child. Pregnant women will not be enrolled in the study. In the 
event that your whole body does not fit into a single scan, we will conduct 2 scans- one of 
the right half of your body and one of the left half.

MS symptoms and functional limitations- You will be asked to complete a series of 
assessments including brief walking tests and tests of cognitive function, which will be 
performed by our trained research staff. These assessments are intended to measure the 
disability and symptoms of MS.

Questionnaires- You will also be asked to complete a series of questionnaires related to 
symptoms of MS such as pain and fatigue. 
14 days after baseline: 

24 Hour Food Recalls: During these 14 days you will be asked to participate in 3 phone 
interviews to complete 24-hour food recalls. A research staff person from UAB will call you 
on three different days and review what you had to eat on the previous day. 

Accelerometer: At the end of the baseline visit, you will be given an accelerometer to wear 
around your waist for 7 days, along with instructions for use.  You will also be given a pre-
stamped envelope in order to return the accelerometer.

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
 We will call you at the end of this 14 day period as a reminder to mail in your 
accelerometer, check on food recall completion, and to schedule your first weekly check-in 
call.
During the Intervention: 

You will eat all of your food over an 8 hour period each day. You will not be told what to 
eat, but you will be given a calorie level that you should not go over each day. 

You will be asked to log all your food, and the time you eat it, onto a website called 
HealthWatch 360. 

You will receive prompts from HealthWatch360 each day to rate your level of hunger, 
fatigue, energy and sleep. 

You will receive a call once each week from the study coordinator. This call is intended to 
review how you are doing with staying on your meal timing schedule, and answer any 
questions you have about the program. During this call, the study coordinator will also ask 
you about any adverse events (side effects, health problems) you have experienced that 
week. 
Midpoint of the Intervention (4 weeks)

You will complete a brief mid-point satisfaction survey to tell us about your experiences in 
the first month of the study. This will be completed on-line, so you do not have to come into 
the lab to complete it.  If you do not have access to a computer with internet, we will mail 
you a copy of the survey. 
Follow up Measures:

At the end of the 8-week program, you will be scheduled to return to the lab to complete 
the same 1 time visit you completed at baseline, plus a few additional questionnaires about 
your experience with the diet. The visits will be the same as those you completed at the 
beginning of the study, with the visit lasting approximately 2 hours.

During the 14 days after the follow up visits, you will again be given an accelerometer to 
wear. You will also complete 3 additional 24-hour food recall phone interviews. At the end 
of the 14 days, you will return the accelerometer using the pre-stamped, pre-addressed 
envelope provided to you at your follow up appointment.
The clinical results (including individual research results) will not be returned to you.

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Incidental Findings
We are performing imaging solely for the research purposes described above. It is not a 
clinical scan intended for diagnostic or therapeutic purposes. Under no circumstance will 
the investigator, research staff, or imaging staff interpret the scan as normal or abnormal. 
They are unable to make any medical comments about your scan. The scan will not be 
looked at or read for any healthcare treatment or diagnostic purpose. If you want your scan 
to be reviewed by a physician to look for medical issues, you can request a copy of your 
scan. We will provide an electronic copy at no charge.
Risks and Discomforts
Fasting Prior to Testing: You may experience a drop in your blood sugar causing 
lightheadedness, dizziness, nausea, sweating, and shakiness. If you experience any of these 
symptoms prior to or during testing, please notify the researcher or technician so they may 
assist you.
Bloodwork:  You may experience pain, bruising, and/or fainting during venipuncture. 
DXA: A DXA scan is an x-ray scan that uses a very low-level of radiation. In this study you will be 
exposed to a very low level of radiation during the DXA scan. The radiation dose received from 
the 1 to 2 scans is equivalent to about 8 days of natural background radiation. Background 
radiation is radiation normally received from sources such as cosmic rays and natural 
radioactivity in building materials and the ground. A small risk of cancer and other radiation 
effects, which may not be known at this time, may develop from each scan you receive.
Changing diet habits: There is a potential risk of hunger when you make changes to your diet. 
We will attempt to reduce this risk by providing options for healthy foods that will not leave 
you hungry. 
Loss of Confidentiality: There is a potential risk of loss of confidentiality regarding exposure of 
personal information obtained by our researchers. All information we obtain about you will be 
kept in a database on a secure UAB server. While using this type of server reduces your risk of 
loss of confidentiality, some risk does remain.
Questionnaires: There are minimal risks associated with completing the questionnaires with this 
study. One foreseeable risk may be psychological in that participants may experience feelings of 
discomfort or embarrassment when reporting on their symptoms or experiences of MS. 
Benefits
You may have changes in body composition and may reduce your risk of heart disease and 
diabetes. You may also have improved physical function and reduced symptoms of pain and 
fatigue. However, it is possible that you will not benefit from this research.

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Alternatives
If you choose not to participate in this research, you may still change your diet on your own. If 
you decide to participate in another research study, you should contact the investigator as this 
may affect your dietary intake related to this study. 
Confidentiality and Authorization to Use and Disclose Information for Research Purposes
Federal regulations give you certain rights related to your health information. These include the 
right to know who will be able to get the information and why they may be able to get it. The 
study investigators must get your authorization (permission) to use or give out any health 
information that might identify you.
What protected health information may be used and/or given to others?
All medical information, including but not limited to information and/or records of any 
diagnosis or treatment of disease or condition, which may include sexually transmitted diseases 
(e.g., HIV, etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal 
identifiers, including but not limited to your name, social security number, medical record 
number, date of birth, dates of service, etc.; any past, present, and future history, 
examinations, laboratory results, imaging studies and reports and treatments of any kind, 
including but not limited to drug/alcohol treatment, psychiatric/psychological treatment; 
financial/billing information, including but not limited to copies of your medical bills; any other 
information related to or collected for use in the research study, regardless of whether the 
information was collected for research or non-research (e.g., treatment) purposes; records 
about any study drug you received or about study devices used; and consent forms from past 
studies that might be in your medical record.
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this website at any time.
Who may use and give out information about you?
Information about your health may be used and given to others by the study investigator and 
staff. They might see the research information during and after the study.
Who might get this information?
All Individuals/entities listed in the informed consent document(s), including but not limited to, 
the physicians, nurses and staff and others performing services related to the research 
(whether at UAB or elsewhere). Your information may also be given to the sponsor of this 
research. “Sponsor” includes any persons or companies that are working for or with the 
sponsor, or are owned by the sponsor, or are providing support to the sponsor (e.g., contract 
research organization).
Information about you and your health which might identify you may be given to:

the Office for Human Research Protections (OHRP)

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
the U.S. Food and Drug Administration (FDA)

Department of Health and Human Services (DHHS) agencies

Governmental agencies in other countries

Governmental agencies to whom certain diseases (reportable diseases) must be reported

the University of Alabama at Birmingham - the physicians, nurses and staff working on the 
research study (whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, 
UAB Highlands Hospital, University of Alabama Health Services Foundation, Children’s of 
Alabama, Eye Foundation Hospital, and the Jefferson County Department of Health, as 
necessary for their operations; the UAB IRB and its staff

the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama and 
its billing agents
Why will this information be used and/or given to others?
Information about you and your health that might identify you may be given to others to carry 
out the research study. The sponsor will analyze and evaluate the results of the study. In 
addition, people from the sponsor and its consultants will be visiting the research site. They will 
follow how the study is done, and they will be reviewing your information for this purpose.
 
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health 
information listed above for the purposes described above. If you refuse to give permission, 
you will not be able to be in this research.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information. However, if you decide to be in 
this study and sign this permission form, you will not be allowed to look at or copy your 
information until after the research is completed.
May I withdraw or revoke (cancel) my permission?
Yes, but this permission will not stop automatically. The use of your personal health 
information will continue until you cancel your permission.
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the study doctor. If you withdraw your 
permission, you will not be able to continue being in this study.
When you withdraw your permission, no new health information which might identify you will 
be gathered after that date. Information that has already been gathered may still be used and 
given to others. This would be done if it were necessary for the research to be reliable.

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Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the 
information may no longer be protected. There is a risk that your information will be released 
to others. Including others outside of UAB, without your permission.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide 
not to be in it. If you decide not to be in the study, you will not lose any benefits you are 
otherwise owed.
You are free to withdraw from this study at any time. Your choice to leave the study will not 
affect your relationship with this institution. 
If you are a UAB student or employee, taking part in this research is not a part of your UAB class 
work or duties. You can refuse to enroll, or withdraw after enrolling at any time before the 
study is over, with no effect on your class standing, grades, or job at UAB. You will not be 
offered or receive any special consideration if you take part in this research.
Cost of Participation
All tests and materials will be provided to you at no cost during the study. You should check 
with your internet and cell phone provider to see about any extra costs. 
Payment for Participation
You will be paid $50 after you complete all baseline measures and $50 when you complete all 
follow up measures. If you complete the entire study, you will be paid a total of $100. Ask the 
study staff about the method of payment for this study (e.g. check, cash, gift card, etc.).
Payment for Research-Related Injuries
UAB has not provided for any payment if you are harmed as a result of taking part in this study. 
If such harm occurs, treatment will be provided. However, this treatment will not be provided 
free of charge.
New Findings
You will be told by the study staff or the primary investigator if new information becomes 
available that might affect your choice to stay in the study.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Questions
If you have any questions, concerns, or complaints about the research or a research-related 
injury including available treatments, please contact the Primary Investigator. You may contact 
Dr. Wingo at 205-934-5982 or by emailing her at bcwingo@uab.edu.

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If you have questions about your rights as a research participant, or concerns or complaints 
about the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll 
free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday 
through Friday.
Email Communication
During this study, we may offer the option to have appointment reminders sent to you by 
unencrypted email. There is a potential risk of loss of confidentiality when communicating via 
unencrypted email. Unencrypted email communication is considered a non-secure method of 
sharing information. There is no guarantee that such communication (and any other data 
associated with it) is private and will only be viewed by the intended recipient. By using 
unencrypted email, you acknowledge and accept this risk.
Please initial your choice below:
______ I would like to communicate via unencrypted email.
______ I do not wish to communicate via unencrypted email.
Signatures
Your signature below indicates that you agree to participate in this study. You will receive a 
copy of this signed document.
Signature of Participant
Date
Signature of Investigator or Other Person Obtaining Consent
Date

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