Evaluate the Use of Omega-3 Fortified Smoothies to Improve Omega-3 Index and Physical Performance Related Outcomes Among Soldiers
Phase: NA
Conditions: Nutrition, Healthy
Sponsor: Uniformed Services University of the Health Sciences

Study Title: The Effect of Omega-3 Fortified Smoothies 
on Omega-3 Index and Physical Performance Related 
Outcomes Among Soldiers
Document date: 4/15/2024 

EIRB Protocol Template (Version 1.4)
1.0
General Information
*Please enter the full title of your study:
Evaluate the use of omega-3 fortified smoothies to improve omega-3 index and physical 
performance related outcomes among Soldiers
*Please enter the Protocol Number you would like to use to reference the protocol:
H2F Omega-3
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify
this protocol.
Is this a multi-site study (i.e. Each site has their own Principal Investigator)?
No
Does this protocol involve the use of animals?
Yes
No
2.0
Add Site(s)
2.1 List sites associated with this study:
Primary 
Dept?
Department Name
R and E - Uniformed Services University of the Health Sciences (USUHS)
3.0
Assign project personnel access to the project
3.1 *Please add a Principal Investigator for the study:
Rittenhouse, Melissa A, PhD
Select if applicable
Student
Site Chair
Resident
Fellow
3.2 If applicable, please select the Research Staff personnel:
A) Additional Investigators
Heileson, Jeffery Lee, Ph.D. MAJ 
Associate Investigator
N

B) Research Support Staff
Khurana, Saachi 
Research Coordinator
PATEL, NEHA Amrish 
Non-engaged Administrator
3.3 *Please add a Protocol Contact:
Khurana, Saachi 
PATEL, NEHA Amrish 
Rittenhouse, Melissa A, PhD 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves).
3.4 If applicable, please select the Designated Site Approval(s):
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair).
4.0
Project Information
4.1  
What department(s) will be associated with this protocol?
*
Emergency Medicine
4.2  
Is the IRB of record for this study an IRB/HRPP that does NOT use EIRB? If Yes, complete the
*
application according to the IRB/HRPP Determination.
If your Projects or Protocols are under the oversight of another IRB that does use EIRB, stop this 
submission and contact the core site and request an invitation as a performing site.
If your Project or Protocol is now being submitted for the first time to an IRB that does use EIRB, 
continue with this application and answer the questions to be reviewed by the IRB.
Answering yes means the board of record is an IRB that does NOT use EIRB.
  Yes   
  No
4.3  
Is this protocol research, expanded access, or humanitarian use device?
*
 Yes   
 No
4.4  
What type of protocol is this?
*
Behavioral Research
Biomedical Research
Clinical trial (FDA regulated)

Educational Research
Expanded Access
Humanitarian Use Device (HUD)
Psychosocial Research
Oral History
Other
4.5  Are you conducting this project in pursuit of a personal degree?
  Yes   
  No
4.7  
Is this human subjects research? (As defined by 32 CFR 219) 
* 
   Human subject means a living 
individual about whom an investigator (whether professional or student) conducting research: 
   (i) Obtains information or biospecimens through intervention or interaction with the individual, and 
uses, studies, or analyzes the information or biospecimens; or 
  (ii) Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens.  
 Yes   
 No
4.8  
 Do you believe this human subjects research is exempt from IRB review?
*
  Yes   
  No
5.0
 
Personnel Details
5.1  Does the Principal Investigator have a Permanent Change of Station (PCS) Date or Estimated 
Institutional Departure Date (EIDD)?
  Yes   
  No
5.2  List any Research Team members without EIRB access that are not previously entered in the protocol:
Name:
(Last, First, M.I.)
Deehl, Christina
Role on Protocol:
Collaborator
Phone Number:
 
270-412-5826
Email Address:
 
christina.e.deehl.
mil@army.mil
Associated 
Institution:
 
Army, Fort 
Campbell
Name:
(Last, First, M.I.)
Lomax, Trevor
Role on Protocol:
Collaborator
Phone Number:
 
NA
Email Address:
 
NA
Associated 
Institution:
 
Army, Fort 
Campbell
Name:
(Last, First, M.I.)
Email Address:

Booke Guttormson
Role on Protocol:
Collaborator
Phone Number:
 
740-641-05727
 
brooke.k.
guttormson.
mil@health.mil
Associated 
Institution:
 
Army, Fort 
Campbell
Name:
(Last, First, M.I.)
Lee, Brandon
Role on Protocol:
Collaborator
Phone Number:
 
315-772-0689
Email Address:
 
brandon.l.lee16.
civ@army.mil
Associated 
Institution:
 
Army, Fort Drum
Name:
(Last, First, M.I.)
Clark, Emily
Role on Protocol:
Collaborator
Phone Number:
 
315-772-0471
Email Address:
 
emily.f.clark10.
mil@army.mil
Associated 
Institution:
 
Army, Fort Drum
5.3  Are any Contractors or Subcontractors involved in this study? If yes, please list them and describe their role.
 Yes   
 No
Name:
(Last, First, M.I.)
Rittenhouse, 
Melissa A
Role on Protocol:
PI
Phone Number:
301-295-2621
Email Address:
melissa.
rittenhouse.
ctr@usuhs.edu
Associated 
Institution:
HJF/USU
5.4  
Will you have a Research Monitor for this study?
Yes 
No 
N/A 
6.0
 
Data/Specimens
6.1  Does the study involve the use of existing data or specimens only (no interaction with human 
subjects)?
  Yes   
  No

7.0
 
Funding and Disclosures
7.1  Source of Funding:
Funding Source
Funding Type
Amount
:
Other
Defense Health Program
:
Other
Total amount of funding:
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study?
  Yes   
  No
All personnel engaged in research must complete and attach a Conflict of Interest (COI) form.
8.0
 
Study Locations
8.1  Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?)
 Yes   
 No
8.2  Study Facilities and Locations:
Institution
Site Name
Site Role
FWA or 
DoD 
Assurance 
Number
Assurance 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing 
for Site
Army
Ft 
Campbell
Performance 
site
DoD
Army
Ft. Drum
Performance 
site
DoD
Other:
Other 
Institution 
Site
Site Role
FWA or DoD 
Assurance 
Number
FWA or DoD 
Expiration 
Date
Is there an 
agreement?
IRB 
Reviewing for 
Site
No records have been added
8.3  Are there international sites?
Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered
  Yes   
  No

8.4  Is this an OCONUS (Outside Continental United States) study?
  Yes   
  No
Select  the area of responsibility:
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval)
  Yes   
  No
9.0
 
Study Details
9.1  Key Words:
Provide up to 5 key words that identify the broad topic(s) of your study
Omega-3 fatty acids, Holistic Health and Fitness (H2F), Army Combat Fitness Test (ACFT), 
Performance, Nutrition
9.2  Background and Significance:
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol.  The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses.  This section establishes 
the relevance of the study and explains the applicability of its findings
Evidence suggests that mental [1-11] and physical [12-17] health are positively related to the 
omega-3 intake, and studies indicate that supplementation of omega-3 fatty acids may improve 
muscle recovery and range of motion while decreasing soreness and pain. [16, 18-21] 
Omega-3 fatty acids are an essential part of the diet and are found primarily in marine-based 
sources of fatty fish including salmon, mackerel, and herring. The Omega-3 Index (O3I) is a 
reliable method used to measure omega-3 status, more specifically it represents the sum of 
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as a percentage of red blood cells. 
Currently, O3I is the preferred method for assessing omega-3 status given its low biological 
variability and its ability to be measured in either the fed or fasted state.  Generally, the O3I 
increases with greater consumption of marine-based omega-3; however, the extent varies by 
individual. Research indicates the general population and Service Members alike have a low O3I 
(~4%) and therefore at risk for poor health and suboptimal physical performance. [22] For 
optimal health, performance and a decreased risk for cardiovascular disease an O3I of ≥ 8 % is 
desirable. 
The research utilizing the Omega-3 Index as a measure of omega-3 fatty acids began in relation 
to preventing severe cardiovascular risks. The research has expanded shows that omega-3 fatty 
acids can reduce triglyceride levels [23, 24] and may serve as an effective treatment option for 
cardiovascular disease, [12, 25] osteoporosis, [26, 27] psoriasis, [28] and arthritis. [29-32] 
Omega-3 fatty acids are thought to inhibit eicosanoids and inflammatory cytokines leading to 
analgesic effects. Additionally, preliminary studies support a rehabilitative role of omega-3 fatty 
acids in maintaining muscle mass and minimizing muscle wasting during a prolonged period of 
limb immobilization (i.e., leg cast). [33] Furthermore, O3I levels have been positively correlated 
with muscle protein synthesis and enhanced recovery from muscle damaging exercise (i.e. 
delayed onset muscle soreness), in both athletic and military populations. [16, 18-21]
Improving Service Members health and maintaining the ability to perform optimally are high 
priorities. An average O3I of ~4% is concerning. These findings, although not surprising given 
the lack of foods containing omega-3 fatty acids across military installations, require action. 
Innovative solutions to provide Service Members with omega-3 fatty acids are needed to achieve 
health and performance benefits. Therefore, the purpose of this study is to examine whether 

increasing omega-3 fatty acid intake using a novel fortified food product improves performance 
and recovery outcomes in Holistic Health and Fitness (H2F) soldiers. 
9.3  
Objectives/Specific Aims/Research Questions:
Describe the purpose and objective(s) of the study, specific aims, and/or research questions
/hypotheses
Objectives 1: 
Assess the impact of 8-weeks of daily consumption of 1600mg of omega-3 fortified 
smoothie on O3I response.
Objective 2: 
Determine the relationship between O3I and measures of performance and recovery.
We hypothesize regular consumption (one smoothie per day, five days per week, for eight 
weeks) of omega-3 enhanced smoothies (1600 mg omega-3 per smoothie) will increase O3I to 
8% compared to a control group. We also hypothesize improvements in performance markers 
related to strength, flexibility, aerobic capacity and power as assessed by the Army Combat 
Fitness Test (ACFT), rate of perceived exertion (RPE), and recovery (a visual analog scale (VAS) 
for pain) in the intervention group compared to control. We hypothesize the control group will 
not reach an O3I of 8% and measures of performance and recovery will be statistically lower 
than in the intervention group. 
9.4  Study Design:
Describe study design in one to two sentences (e.g., prospective, use of existing records/data
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase – Phase I, II, III, or IV – for FDA-regulated investigational drug 
research
A double blind randomized-placebo control trial will be conducted in collaboration with the Army 
Holistic Health and Fitness (H2F) Program. Participants will be randomly selected from two H2F 
training sites: Ft. Campbell and Ft. Drum. In total, 100 participants will be randomly selected, 50 
per site. Each site will have 25 participants assigned to the placebo group and 25 participants 
assigned to the omega-3 enhanced smoothie group. All interested soldiers will enter their name. 
Participants will be randomly selected until 100 participants consent. Participants will be excluded 
if they have a fish allergy or if they are unable to complete an Army Combat Fitness Test (ACFT) 
for any reason. Participants taking omega-3 supplements will not be excluded, but will be 
instructed to be consistent for the duration of the study. 
9.5  Target Population:
Describe the population to whom the study findings will be generalized
Soldiers
9.6  Benefit to the DoD:
State how this study will impact or be of benefit to the Department of Defense
Previous research already indicates omega-3 status is low in military personal. Increasing omega-
3 fatty acid intake will not only help maintain a healthy force by minimizing chronic disease risks, 
if we determine omega-3 fatty acids improve performance or recovery, then guidelines can be 
developed and soldiers can be educated and the demand for these types of foods will lead the 
way in improving the military nutrition environment.

1.  
2.  
1.  
1.  
2.  
3.  
10.0
 
Study Procedures, Data Management, and Privacy
10.1  Study Procedures:
Describe step-by-step how the study will be conducted from beginning to end
This is an 8-week protocol with baseline and post-intervention data collections including: 
demographics, digitized questionnaires (nutrition, physical activity and sleep), O3I (collected by 
finger prick) and ACFT scores. We will assess changes in O3I status, performance on, and 
recovery from the ACFT at two H2F training sites (Ft. Campbell and Ft. Drum), after providing 
omega-3 enhanced or placebo smoothies. All smoothies will be pre-made, iso-caloric and 
provided in similar ready to drink containers. Researchers and participants will be blinded, one 
staff member will not be blinded and maintain the key identifying which participants receive the 
placebo vs intervention. A smoothie log based on participant ID will be coded (i.e., A or B) to 
assist in distribution of the smoothies. Each smoothie will have a lot number that ends in A or B. 
Baseline visit: To account for potential confounding factors, dietary intake assessed using the 
Health Eating Score (HES), daily physical activity using the Physical Activity Questionnaire (PAQ), 
and sleep using the Pittsburg Sleep Quality Index (PSQI) sleep questionnaire will be collected 
using REDCap. O3I will be collected by finger prick. A baseline ACFT will be conducted by trained 
Army staff (not researchers). The ACFT scores will be reported to the researchers by the 
participants. Participants will log into REDCap to report their ACFT score and report the Rate of 
Perceived Exertion (RPE), a score of 6-20 and the pain score, ranging from 0-10. This will be 
recorded one hour and 24 hour post ACFT.
Intervention: To ensure compliance, participants will be provided an omega-3 smoothie or 
placebo daily (Monday-Friday) by brigade dietitians or assigned staff immediately following 
training. 
Post-Intervention data collection: After eight weeks of intervention O3I, questionnaires and 
ACFT scores will be collected again with participants reporting their RPE and pain scores following 
the same format as the baseline visit.
Participants will be given a USU-approved tablet to complete a digitalized participant’s 
questionnaire, utilizing a USU-secure web based platform such as REDCap or will be emailed an 
anonymous survey link. Using this link, they will access REDCap to complete the questionnaires 
on their laptop or phone. No personally identifiable information nor personal health information 
will be recorded in the questionnaires. Methods to complete the questionnaire are outlined below:
Use a USU-approved tablet to complete the questionnaire using the USU REDCap 
capabilities.
Use their personal phone or laptop to complete the questionnaire using the USU REDCap 
capabilities.
 Research staff will email them two options to access questionnaire via REDCap
Website link with an accompanying Access Code 
QR code to access the electronic consent documents
Paper questionnaires will be available in case there are technical issues. 
10.2  Data Collection:
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured.
Omega-3 Index This requires a finger prick with a lancet, similar to how a person with diabetes 
would check their blood sugar levels. This method will be used to obtain 1-2 drops of blood that 
will be placed on the provided collection card and sent to OmegaQuant to determine the Omega-
3 Index.
Procedures for participants The Omega-3 kit include an alcohol pad to clean the finger, a blood 
collection card, a lancet, gauze and bandage. Instructions are included. Researchers will be 
assisting with the finger pricks.

1.  
2.  
1.  
1.  
2.  
3.  
Participants are instructed to: 1. Wash their hands with warm water, hold their arm down at their 
side for 20 seconds. 2. Use the alcohol pad to clean the index, middle or ring finger and remove 
any excess liquid with the gauze. 3. Twist off the blue plastic lancet cover. Place the lancet lightly 
on the side of the finger. Press down firmly onto the finger until you hear a click. Allow a drop of 
blood to collect on the finger. Lightly squeeze if needed. Then lightly touch the drop of blood to 
the dotted circle on the blood collection card. Completely fill the circle with blood. 4. When 
finished, apply pressure to the figure with the gauze pad and apply adhesive bandage. 5. Let the 
blood spot dry for 15-20 minutes then fold the collection card flap and place the card in the 
plastic bag. 6. Dispose of all materials in the trash.
Army Combat Fitness Test (ACFT) This is the standard fitness test for the soldiers. An ACFT 
will be conducted by trained staff at week 1 of the study and week 8. These will be standard 
practice ACFTs for the entire company (not only those in research). 
Rate of Perceived Exertion (RPE) Immediately after the ACFT participants will be asked on a 
scale of 6-20 the how hard they were working during the ACFT. 
Defense and Veterans Pain Scale Participants will report their pain score one hour and twenty 
four hours after each ACFT. Participants are shown a scale ranging from 0-10 with the picture of 
a face and a description that best matches how they feel. 
Healthy Eating Score (HES) On the demographics questionnaire we also include 8 healthy 
eating questions. This will allow us to assess if there were any changes in diet throughout the 
duration of the study, and captures fish intake.
Diet ID An electronic method of capturing dietary intake that provides a complete picture of 
nutrient intake. Here is a product demo video: https://vimeo.com/665298627
Pittsburgh Sleep Quality Index (PSQI) PSQI will be utilized to qualitatively assess 
participants' sleep quality. The PSQI is a 19-item questionnaire that calculates sleep quality over 
the past month and assesses the following dimensions: sleep quality, sleep latency, sleep 
duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime 
dysfunction. The PSQI generates a global score ranging from 0 – 21 with higher scores 
demonstrating worse sleep quality. Scores higher than 5 reflect poor sleep quality (clinical 
insomnia). The instrument takes 5 – 10 minutes to complete. It has been used in various 
populations. A global PSQI score > 5 yielded a diagnostic sensitivity of 89.6% and specificity of 
86.5% (kappa = 0.75, p < 0.001) in distinguishing good (healthy subjects) from poor sleep.
Physical Activity Questionnaire (PAQ) The Physical Activity Questionnaire is an 8-item scale 
to assess weekly exercise patterns.
Participants will be given a USU-approved tablet to complete a digitalized participant’s 
questionnaire, utilizing a USU-secure web based platform such as REDCap or will be emailed an 
anonymous survey link. Using this link, they will access REDCap to complete the questionnaires 
on their laptop or phone. No personally identifiable information nor personal health information 
will be recorded in the questionnaires. Methods to complete the questionnaire are outlined below:
Use a USU-approved tablet to complete the questionnaire using the USU REDCap 
capabilities.
Use their personal phone or laptop to complete the questionnaire using the USU REDCap 
capabilities.
 Research staff will email them two options to access questionnaire via REDCap
Website link with an accompanying Access Code 
QR code to access the electronic consent documents
Paper questionnaires will be available in case there are technical issues. 
10.3  At any point in the study, will you request, use, or access health information in any form, including 
verbal, hard copy and electronic?
  Yes   
  No
10.14  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 

this Study:
Include in this section the plan for acquiring data (both electronic and hard copy), access during 
the study, data/specimen storage and length of time stored, shipment/transmission, and the 
plan for storage and final disposition at the conclusion of the study. Describe any data 
agreements in place for accessing data within and/or outside of your institution (e.g., Data 
Sharing Agreement, Data Use Agreement, Business Agreements, etc.)
A password protected master key will be managed by USU researchers and will be the only 
document that contains the participant name and participant identification number. The master 
key will be shared between performance sites and researchers via DoDSAFE. The performance 
site researchers will use this key to prevent errors when distributing the smoothies.  If a hard 
copy of the master key is needed to assist distribution of the smoothies it will be stored in a 
locked draw in collaborator's office at the performance sites and shredded after all the results of 
the study have been obtained. Only aggregated results of this research will be presented at a 
conference and a manuscript will be developed.
Is this a data repository?
  Yes   
  No
10.15  Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research:
If the study involves collecting, storing, or banking human specimens, data, or documents 
(either by the Investigator or through an established repository) for FUTURE research, address. 
How the specimens/data will be used, where and how data/specimens will be stored (including 
shipping procedures, storage plan, etc.), whether and how consent will be obtained, procedures 
that will fulfill subjects’ request as stated in the consent, whether subjects may withdraw their 
data/specimens from storage, whether and how subjects may be recontacted for future research 
and given the option to decline, whether there will be genetic testing on the specimens, who will 
have access to the data/specimens, and the linkage, the length of time that data/specimens will 
be stored and conditions under which data/specimens will be destroyed.
N/A
Is this a data repository?
  Yes   
  No
11.0
 
Statistical/Data Analysis Plan
11.1  Statistical Considerations:
List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses.  Explain how missing data and outliers will be handled in the 
analysis.  The analysis plan should be consistent with the study objectives.  Include any sub-
group analyses (e.g., gender or age group).  Specify statistical methods and variables for each 
analysis.  Describe how confounding variables will be controlled in the data analysis
We plan to analyze results using multiple regression analysis whereby we will regress outcomes 
(O3I, ACFT scores) onto treatment-allocation, controlling for pre-treatment factors (e.g., pre-
O3I, demographics). This is equivalent to a two-group ANCOVA. For most analyses, we aim to 
keep outcomes continuous. In sensitivity analyses, we will also dichotomize O3I (e.g., at 8%, 
which is the cutoff for healthy O3I), examine mixed generalized linear models, and examine the 
design-effect of each site (which may decrease power somewhat). Alternative model 
specifications or variable-transformations will be considered in cases where gross violations 
invalidate certain approaches.
11.2  Sample Size:

80-100 participants
11.3  Total number of subjects requested (including records and specimens):
100
11.4  If you are recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm
N/A
11.5  Please provide a justification for your sample size
Power calculations, performed using the pwr2ppl package in r (https://www.routledge.com
/Applied-Power-Analysis-for-the-Behavioral-Sciences-2nd-Edition/Aberson/p/book
), were executed based on the expected associations between treatment 
/9781138044593
allocation (i.e., treatment vs control) and the outcome variables (post-O3I, ACFT scores), 
controlling for baseline statuses (e.g., pre-O3I). We also assumed there would 20% be missing 
data or attrition, and that baseline statuses would not be associated with treatment allocation. 
Alpha was set alpha at 0.05 and power at 0.8. Under these conditions, with an analytic sample 
size of 80 subjects, and assuming a correlation between pre- and post-O3I (or pre- and post-
ACFT score) of 0.6, the study will be adequately powered to detect an association of 
= 0.25 
r 
between treatment allocation and the outcome. This converts into a cohen's d (or standardized-
unit difference) of 0.55. This is generally considered a moderate-to-strong effect size. Based on 
previous research examining distribution and change in O3-I in similar samples, this would likely 
be equivalent to a treatment-effect of of 0.6%-unit increase in O3-I. If there is a weaker 
association between pre- and post-O3I (or other outcomes), then the minimal detectable effect 
size would increase (e.g., if the pre/post association is 0.4, then the minimal detectable effect 
would be a Cohen's d of 0.6); if there is a stronger association between pre- and post-O3I, then 
the minimal detectable effect size would decrease (e.g., if the pre/post association is 0.8, then 
the minimal detectable effect would be a Cohen's d of 0.4).
11.6  Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan:
In addition to the analyses indicated in 11.1, additional measures will be undertaken to ensure 
that data are of high-quality over the course of the study, including double data entry where 
relevant, periodic inspection of data as it is collected, and periodic preliminary analyses. 
Statistical packages to be used will primarily include Microsoft Office Excel and IBM SPSS.
12.0
 
Participant Information
12.1  Subject Population:
Holistic Health and Fitness Soldiers
12.2  Age Range:
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box.
0-17
18-24
25-34

35-44
45-54
55-64
65-74
75+
12.3  Gender:
Male
Female
Other
12.4  Special categories, check all that apply
Minors /Children
Students
Employees - Civilian
Employees - Contractor
Resident/trainee
Cadets /Midshipmen
Active Duty Military Personnel
Wounded Warriors
Economically Disadvantaged Persons
Educationally Disadvantaged Persons
Physically Challenged (Physical challenges include visual and/or auditory impairment)
Persons with Impaired Decisional Capacity
Prisoners
Pregnant Women, Fetuses, and Neonates
Non-English Speakers
International Research involving Foreign Nationals - Headquarters Review is necessary
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraph 7.e.
12.5  Inclusion Criteria:
Order 
Number
Criteria
1 
Current soldier at Ft. Drum or Ft. Campbell.
 
2 
Able and willing to complete two Army Combat Fitness Test (ACFT) (Week 1 and 
week 8)
 
3 
Willing to obtain two finger pricks for the Omega-3 Index (week 1 and week 8)
 
12.6  Exclusion Criteria:
Order 
Number
Criteria
1 
Allergic to fish
 

13.0
 
Recruitment and Consent
13.1  Please describe the recruitment process, including how subjects will be identified and selected for 
the study.
Recruiting
Recruitment will be done by briefing select companies where command has approved the soldiers 
to participate (See recruitment brief). Volunteers who are interested and meet the eligibility 
criteria will provide their name and email address. Once recruitment has ended participants will 
be randomly selected to participate and notified by email. Participants selected will review the 
eICD with researchers. Once all 100 participants are selected and have signed the electronic 
informed consent (eICD) they will be allocated to either the intervention (smoothie enhanced 
with omega-3) or placebo (smoothie with no omega3) group.
13.2  Compensation for Participation:
N/A
13.3  Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor
N/A
13.4  Consent Process:   Revised Common Rule, Section 219.116:  General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 
(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens.
Are you requesting a waiver or alteration of informed consent?
  Yes   
  No
Please explain the consent process:
Consenting
Participants that are interested and eligible will review the ICD with a member of the research 
team. The participant will be encouraged to ask any questions he/she has, both in writing as part 
of the ICD and verbally by the person conducting the consent process. Once all questions have 
been answered to the volunteer’s satisfaction, he/she will be given a USU-approved tablet to do 
an electronic (e) consent using the USU REDCap capabilities.They will provide an e-signature and 
a copy of the consent form will be emailed to them with their permission. Once the consent 
document is signed, they will be enrolled in the study. As an alternative, paper ICD forms will be 
available in case there are technical issues.
13.5  DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman.
N/A 
Propose ombudsman 
13.6  Withdrawal from Study Participation:

Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study
Information about processes for withdrawing from the study will be provided to participants at the
 
time of consent. A participant may decide to withdraw from the study at any time. Refusal to part
 
icipate will involve no penalty or loss of benefits to which the subject is otherwise entitled and 
 
the subject may discontinue participation at any time without penalty or loss of benefits to which 
 
the subject is otherwise entitled. If a participant withdraws, any previously collected data will be 
 
retained unless they provide written request for removal of your data in the withdrawal letter.
 
14.0
 
Risks and Benefits
14.1  
Risks of Harm:
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study.  Consider the risks of breach 
of confidentiality, psychological, legal, social, and economic risks as well as physical risks.  Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes
All of the research procedures described are associated with minimal risk, but there are still 
expected risks and potential reasons to stop data collection. For example, there is potential risk 
associated with the finger prick. Participants may experience some discomfort, and some 
bruising and/or transient pain at the site of the finger prick. In addition, there are slight risks of 
infection. There is also a risk of an allergic reaction, if a participant has an unknown food allergy.
14.2  
Measures to Minimize Risks of Harm (Precautions, safeguards):
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel
To minimize risk participants will be given specific instructions to clean the finger with an alcohol 
pad prior to the O3I prick. Participants will be informed they can put ice on their finger if it is 
sore, or to minimize potential soreness. During the consenting process participants will be 
informed of common signs of infection, including redness and swelling, and instructed to go the 
medical clinic if they have any symptoms 24 hours after the finger prick.
To minimize harm from an allergic reaction researchers will monitor participants as they drink 
the beverage and watch for any signs of intolerance. Medical help will be called if there are signs 
or symptoms of an allergic response.
14.3  
Confidentiality Protections (for research records, data and/or specimens):
Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., use of passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e.
g., child or spouse abuse

Records of participation in this research study may only be disclosed in accordance with state 
and federal law, including the Federal Privacy Act, 5 U.S.C.552a, and its implementing 
regulations. DD Form 2005, Privacy Act Statement - Military Health Records, contains the Privacy 
Act Statement for the records. A copy of DD Form 2005 can be given upon request, or you can 
read on-line at: http://www.dtic.mil/whs/directives/infomgt/forms/eforms/dd2005.pdf. 
Procedures to protect the confidentiality of the data in this study include, but are not limited to 
assigning a unique participant ID that will be used on all data collections. All forms will be kept in 
a restricted access, locked cabinet for five years after the study completion. Following this time 
period, any documentation will be destroyed or erased. To enhance the privacy of the 
information, survey data will be entered directly into a USU secure database such as REDcap by 
the participant. Individual responses are not identified and will be password protected. After 
verification of the database information, paper copies of all materials containing identifiers will be 
shredded five years after completion of the study. Researchers will make every effort to protect 
your privacy and confidentiality; however, there are risks of breach of information security and 
information loss. All efforts will be made to keep the personal information private. Information 
may be shared with the USUHS Institutional Review Board. Complete confidentiality cannot be 
promised for military personnel, because information regarding your health may be required to 
be reported to appropriate medical or command authorities to ensure the proper execution of the 
military mission, including evaluation of fitness for duty.
14.4  
Potential Benefits:
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society
If the individuals in the research are considered experimental subjects (per 10 USC 980), and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects
The potential benefits include enhanced knowledge about how individual dietary habits influence 
the Omega-3 Index. There is also a potential benefit to performance or recovery.
14.5  
Privacy for Subjects:
Describe the measures to protect subject’s privacy during recruitment, the consent process, and 
all research activities, etc.
Participants will only express interest in the study at the brief, selection will not occur until after; 
therefore, nobody will know who is selected unless the participant tells others they are 
participating. During the study, the smoothies will be handed out at a set location close to the 
training facility, but not where everyone in the company can see.
Records of participation in this research study may only be disclosed in accordance with state 
and federal law, including the Federal Privacy Act, 5 U.S.C.552a, and its implementing 
regulations. DD Form 2005, Privacy Act Statement - Military Health Records, contains the Privacy 
Act Statement for the records. A copy of DD Form 2005 can be given upon request, or can read 
on-line at: http://www.dtic.mil/whs/directives/infomgt/forms/eforms/dd2005.pdf. During data 
collection no identifiable information will be collected. All data will only be recorded by participant 
ID number. Surveys are stored on a password protected secure USU REDcap database.
14.6  
Incidental or Unexpected Findings:
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject’s participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 

results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 
results to appropriate military or civilian authorities and explain the potential impact on the 
subject
Information collected through data collection for this study consists of coded data. This 
information is unlikely to expose a medically-sensitive concern. If found, the Principal 
Investigator will notify our Medical Director and appropriate Office of Human Research contact.
Similarly, data collected is unlikely to expose findings for which a researcher would be mandated 
to report results to appropriate military or civilian authorities.
15.0
 
Study Monitoring
15.1  Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB).
DSMP 
DSMB 
Both 
Not Applicable 
16.0
 
Reportable Events
16.1  Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met
 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short-
term management and any long-term implications of each expected event)
 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event
Participation in the study should not entail any physical or mental risk beyond those described. 
In the event of a medical emergency while participating in the study, treatment and care will be 
provided. Information about procedures for providing medical care to participants is disclosed in 
the informed consent process with participants. Any events will be reported to USU IRB.
We do not anticipant risk of many adverse or reportable events. Some potential expected risks 
may include: participants that do not like the drink taste or consistency may have a food 
aversion. In this event, participants will be asked if there is anything different that could be done 
to enhance their experience (ie. make the drink colder), if there isn't anything these participants 
may want to drop out.
Another potential risk is that participants who physically pushed themselves really hard may not 
be able to tolerate food or beverage immediately after finishing PT. In this scenario, researchers 
will let the participant rest and recovery and make sure they feel better before providing the 

smoothie. We will recommend participants drink the smoothies within 30-60 minutes after 
finishing PT. This will allow the body time to adapt.
17.0
 
Equipment/non-FDA Regulated Devices
17.1  Does the study involve the use of any unique non-medical devices/equipment?
  Yes   
  No
18.0
 
FDA-Regulated Products
18.1  Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
Drugs
Dietary Supplements
Biologics
Devices
N/A
18.5  Sponsor (organization/institution/company):
N/A
If applicable, provide sponsor contact information:
19.0
 
Research Registration Requirements
19.1  ClinicalTrials.gov Registration:
Registration is not required 
Registration pending 
Registration complete 
19.2  Defense Technical Information Center Registration (Optional):
Registration is not required 
Registration pending 
Registration complete 
20.0
 
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20.2  Abbreviations and Acronyms:
Army Combat Fitness Test (ACFT)
Docosahexaenoic acid (DHA)
Eicosapentaenoic acid (EPA) 
Health Eating Score (HES)
Holistic Health and Fitness (H2F)
Omega-3 Index (O3I)
Physical Activity Questionnaire (PAQ)

Pittsburgh Sleep Quality Index (PSQI)
Rate of Perceived Exertion (RPE)
Uniformed Services University (USU)