Effects of Different Sources of Beef and Plant-based Meat Alternatives on Postprandial Inflammatory and Metabolic Profiles of Consumers
Phase: NA
Conditions: Inflammatory Response
Sponsor: Utah State University

 
435.797.1821    |    1450 Old Main Hill    |    Logan, UT 84322    |    MAIN 155    |    irb@usu.edu    |     FWA#00003308 
Approval of the Convened IRB 
 
 
From:  
Melanie Domenech Rodriguez, IRB Chair                                                        
Nicole Vouvalis, HRP Director                                                         
To: 
 
Stephen van Vliet 
Date: 
 
March 17, 2022 
Protocol #: 
12499 
Title: 
Effects of Different Sources of Beef on Inflammatory and Metabolic Profiles of Consumers 
 
Your proposal has been reviewed and approved by the Institutional Review Board (based on the Belmont Report and Department 
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The IRB wishes you success with your research. 
 
 

IRB# #12499 
Date: 1-11-2022 
Research Summary 
 
 
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TITLE: Effects of Different Sources of Beef on Inflammatory and Metabolic Profiles of 
Consumers 
 
PRINICIPAL INVESTIGATOR: 
Stephan van Vliet, PhD 
Department of Nutrition, Dietetics and Food Sciences 
Utah State University  
stephan.vanvliet@usu.edu 
T: 435-797-5369 C: 217-778-5001  
TABLE OF CONTENTS 
1. 
BACKGROUND AND SIGNIFICANCE .................................................................................................................... 2 
2. 
STUDY OBJECTIVES ............................................................................................................................................... 2 
3. 
DESIGN AND PROCEDURES ................................................................................................................................... 2 
3.1 Study duration ............................................................................................................................................................ 2 
3.2 Participants ................................................................................................................................................................ 2 
3.3 Study Schedule........................................................................................................................................................... 3 
4. 
SUBJECT RECRUITMENT AND COMPENSATION ................................................................................................ 6 
4.1 Recruitment................................................................................................................................................................ 6 
4.2 Compensation ............................................................................................................................................................ 7 
5. 
RISK/BENEFIT ASSESSMENT ................................................................................................................................. 7 
6. 
COSTS TO THE SUBJECT ........................................................................................................................................ 7 
7. 
ANALYTICAL PROCEDURES AND STATISTICAL CONSIDERATIONS.............................................................. 7 
8. 
DATA STORAGE AND CONFIDENTIALITY .......................................................................................................... 8 
9. 
DATA SAFETY AND MONITORING ....................................................................................................................... 9 
10. LITERATURE ............................................................................................................................................................ 9 
 
 
 

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1. BACKGROUND AND SIGNIFICANCE   
An increasing number of people is interested in consuming either grass-fed beef or plant-based 
beef alternatives, such as the Impossible BurgerTM or Beyond MeatTM, believing that these choices are 
beneficial for consumer health; however, little to no work has been performed to study these beliefs and 
claims. The purpose of this study is to evaluate effects of plant-based meat, grass-fed beef, and grain-fed 
beef on postprandial plasma inflammatory and metabolite profiles in middle aged adults (30-60 y old). 
This work will offer new insight into manipulating the acute, post-meal inflammatory state by consumer 
food choices. It will also provide more insight how food-derived metabolites impact systemic 
metabolites in the human body through metabolomics analysis. This study will utilize a randomized 
cross-over design and every participant will consume each type of meat on three separate occasions 
separated by a minimum of three days.  
 
2. STUDY OBJECTIVES 
 
o To determine the effects of consuming 9 oz of the Impossible BurgerTM, grass-fed beef or 
grain-fed beef on 300 min postprandial plasma inflammatory markers (IL-6, TNF-α, C-
reactive protein, and VCAM-1).  
 
o To determine effects on plasma metabolites (vitamin and mineral derivatives, phenolics, 
amino acids etc.) collected through regular urine sampling during the 300 min postprandial 
phase (at 60 min, 180 min, and 300 min). 
 
o To determine the effects on subjective satiety at 30, 60, 90, and 120 min and every hour 
thereafter following consumption. 
 
3. DESIGN AND PROCEDURES 
 
3.1 Study duration 
 
The study timeline for this protocol is a minimum of 3-4 weeks depending on participant and 
study staff availability.   
 
3.2 Participants 
We will include up to 40 middle aged adults (30-60 years) in this study. Inclusion/exclusion 
criteria are listed below.  
 
Inclusion criteria:  
• Age ≥30 and ≤60 years;  
• BMI ≥25 and ≤35 kg/m2;  
• Weight stable in last 3 months (Loss or gain <4%); 
• Hemoglobin A1C (HbA1C) ≤6.4%;   
• Fasting plasma glucose concentration <126 mg/dl; 
• For the safety of the participant and proper consent of the procedures, subjects must 
be able to speak and understand English to participate in this study 
 

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Exclusion criteria:  
• Use of medications that are known to affect the study outcome measures (e.g., NSAIDs, 
corticosteroids) or increase the risk of study procedures (e.g., anticoagulants) that 
cannot be temporarily discontinued for this study; 
• Consuming >14 drinks per week; 
• Use of cigarettes (or other tobacco products) in last 3 months; 
• COVID vaccine within the last two weeks; 
• Engaged in high-level competitive exercise (e.g., triathlon, marathon, powerlifting); 
• Any 
inflammatory 
diseases 
(e.g. 
autoimmune 
diseases, 
coeliac 
disease, 
glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis); 
• Diagnoses of active malignancy, congestive heart failure, diabetes mellitus and/or 
chronic obstructive pulmonary disease;  
• Use of antibiotics in last 60 days; 
• Pregnant or planning to in the next month*; 
• Lactating women; 
• Soy allergy; 
• Persons who are unable or unwilling to follow the study protocol or who, for any 
reason, the research team considers not an appropriate candidate for this study, 
including non-compliance with screening appointments or study visits. 
 
 
* Participants that are pregnant or planning on becoming pregnant in the next month are excluded. The 
justification is the documented alterations in metabolism that occur during pregnancy (Lain and 
Catalano, 2007), which would impact our metabolomics analysis in this study.  
 
3.3 Study Schedule 
 
Participants will be asked to complete one screening/consent visit and three testing visits throughout 
their participation in the study. All visits will take place in clinical research space located at the Center 
for Human Nutrition Studies (CHNS). The research team will accommodate the availability of the 
research participants, including weekend days if needed. The table below describes these activities.  
 
Visit 
Timepoint 
Activities 
Location 
Duration 
Phone Screen 
Week 1 
-   Pre-screening questions to 
determine eligibility. 
Virtual 
15 min 
Consent 
Week 1 
- Consent (online or in person) 
Virtual or CHNS 
1 hour 
Screening 
Week 1 
- Height/weight 
- Blood draw 
- Screening questionnaires 
CHNS 
1 hour 
Metabolic visit  
(3 visits 
separated by 
3-7 days) 
Week 2-4 
- IV Placement 
CHNS 
 
7 hours each 
- Eat study provided meal 
- Postmeal phase (300 min) 
- Regular urine and blood collection 
 

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Phone Screen (Week 1. Duration: 15 min): Interested participants will be pre-screened by telephone, 
using a scripted list of questions (see attached) to identify individuals that may be eligible for study 
entry. Suitable candidates will then be provided a REDCap survey link to complete additional screening 
questions that asks them further details about their health, dietary habits, and sleep habits (see 
inclusion/exclusion criteria). Only the minimum PHI will be collected to determine eligibility. 
Responses will be reviewed by a study team member (all study team members will have completed the 
necessary CITI training) and potentially eligible candidates will be contacted to schedule a 
consent/screening visit. The pre-screen is put in place to confirm that the participant meets most of the 
inclusion/exclusion criteria before the subject is scheduled for a consent meeting. The phone screen is 
thus performed to limit the amount of ineligible research participants that are consented/screened that 
could easily be excluded by means of a phone screening. This would also provide interested participants 
with the opportunity to ask additional questions about the study and to determine if they are interested in 
moving forward with a consent/screening visit. This will limit both subject and research staff time 
burden.  
 
Consent Visit (Week 1. Duration: 1 hour): This visit can be done virtually through Zoom or occur in 
person in the Center for Human Nutrition Studies (CHNS) at Utah State University. Potential subjects 
will attend a consent session conducted by a trained member of the research staff to present the details of 
the study. Interested participants will complete the informed consent process privately with 
study staff. We will allow up to 60 minutes for the subjects to read the consent and ask questions. If a 
subject wants additional time to think about the study, this will be allowed. The study team will contact 
the subject three days after the initial consent visit ask if he or she has come to a decision. No study 
procedures will take place before written consent is obtained. To minimize subject burden, participants 
will be instructed during the phone screen that they have to opportunity to combine the consent visit 
with their screening visit (see below). If participants wish to combine visits, they are instructed that they 
will have to perform this visit in the morning after an overnight, 12-hour fast.  
 
Screening Visit (Week 1. Duration: 1 hour): This visit will take place at the Center for Human 
Nutrition Studies (CHNS) and will last approximately 1 hour. We ask participants to come in during the 
morning after an overnight, 12-hour fast. During this visit the following procedures will be performed: 
 
o Blood Draw: A trained phlebotomist (the PI) will draw a fasted blood sample for routine 
blood work (see table 2 below) to ensure the participant qualifies for the study. Using a small 
needle, 12 ml blood will be collected from a vein in the participant's forearm or hand. Blood 
samples will be sent to LabCorp to be analyzed for HbA1C, Glucose, Basic Metabolic Panel 
(BMP), and Lipid panel. The blood of women of childbearing potential will be subject to a 
pregnancy test (hCG) as part of this screening blood draw. This will also occur through 
LabCorp. 
 
o Body mass and height. Height (cm) will be measured without shoes. Body mass (kg) will be 
measured without shoes, coats, or sweaters. BMI will be calculated as body mass (kg) / 
height (m)2. 
 

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o Blood pressure: A blood pressure measurement will be taken using an automated upper arm 
blood pressure monitor (Omron BP5250). A total of three measurements will be taken and 
the average value of those will be collected for participant characterization.  
 
o Questionnaires: Participant will be given a three-day food and sleep log to fill out for three 
days prior to each of the metabolic visits described below. The participant will also be given 
a food frequency questionnaire once at the beginning of the study, which will ask them about 
how often they consume animal products and if they are any of the following: “grass-fed, 
organic, pasture-raised, or bought on a farmers market”. This will give us an indication of the 
habitual consumption of pasture-raised animal products of the participants. The food 
frequency questionnaire that will be used is a modified version of the Diet History 
Questionnaire III (NIH) with a 5-point ordinal scale as adapted from Baudry et al. (2015) 
(see attachment). The questionnaire reviews food and beverages typically consumed over the 
past year and takes approximately 30 minutes to complete. 
 
Metabolic visits (Weeks 2-4. Number of Visits: 3. Duration: 7 hours each): These three visits will 
take approximately 7-hours each and will take place at The Center for Human Nutrition Studies 
(CHNS).  Visits will be at least 3 days apart. Participants are required to fast for 12 hours prior to 
reporting to the laboratory. During this, participants will complete the following: 
 
o Meat consumption: Using a randomized cross-over design, participants will ingest 250 g (9 
oz) of an Impossible BurgerTM burger (plant), a grain-fed beef burger (grain-fed), a grass-fed 
beef burger (grass-fed). The meat will be stored as 9 oz. (250 g) patties in designated food 
freezers (-40 °C) in the NDFS kitchen and thawed overnight in a refrigerator (4 °C) prior to 
the subject’s arrival the next morning. The meat will be cooked on a griddle in the CHNS 
metabolic kitchen on each side until an instant-read meat thermometer registers an internal 
temperature of 160 °F (71 °C). The patties will then be immediately served to the participant. 
Participants are provided with a standardized amount of water (1.5 liters) to drink during the 
300 min post-meal phase. Participants will be asked to eat and drink the water at a 
comfortable rate but to try and finish within 30 min. No other food is allowed to be 
consumed during the ensuing 300 min postprandial phase. No other liquids are allowed to be 
consumed during that time as this would interfere with our protocol (see urine collection 
below). Subjects are also expected to remain seated in a chair during this time and can 
work/read/or watch entertainment on their own electronic device. Participants will be 
allowed to get up and use the rest-room; however, we will ask participants to remain 
sedentary otherwise.  
 
o Blood Draws: An intravenous catheter (IV) will be temporarily placed into a forearm or 
hand vein by a trained member of the study team (the PI) to collect repeated blood samples. 
The catheter will remain viable by a slow drip of saline. We will collect four samples total 
(10 mL each; 40 mL or 2 ½ tablespoons) on each of the three metabolic visits. One sample 
will be collected right before participants eat and three more samples will be collected at 60, 
180 min and 300 min after they consume the meal. These draws will be taken in a private 
room in clinical facilities, in a reclining leather chair. Participants will be provided with their 

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clinical lab results that will be obtained from LabCorp. Results from bloodwork will be 
shared with participants via encrypted email using a USU email account. 
 
o Urine Collection: A baseline urine sample will be collected prior to food consumption. 
Participants are asked to completely empty their bladder prior to food consumption. After 
food consumption, all urine will be collected in a urine jug (a 3000 mL urine collection 
bottle) during the 300-minute postprandial phase to study metabolites in the urine. All urine 
collections will be done by the participant themselves in private restroom facilities. 
 
o Satiety Scale: Participants are asked to mark a satiety scale (Holt et al., 1995) at 30, 60, 90, 
120 min, and every hour thereafter until 300 min to assess subjective satiety after meat 
consumption. 
 
Dietary and activity control: We will ask participants to maintain their habitual diet, physical activity, 
and sleep levels. We will ask participants to fill in 3-day dietary and sleep logs for the three days prior to 
their metabolic visit (see attachments). We will also ask them to refrain from alcohol and strenuous 
physical activity (running, weightlifting etc.) for 2 days prior to each metabolic visit. The dietary and 
sleep logs will give us insight if lifestyle factors leading up to each visit were similar and are likely to 
promote compliance to ensure robust biomarker results (inflammatory cytokines and metabolomics). 
Participants are asked to replicate their 3-day foods logs and sleep schedule as much as possible prior to 
each visit. Participants are also asked to not consume red meat or soy (main ingredient of plant burger) 
the day before each visit. This is done to minimize any prior presence of common red meat and soy-
derived metabolites in the urine. 
 
Table 2. Schedule of sample collection  
 
4. SUBJECT RECRUITMENT AND COMPENSATION 
 
4.1 Recruitment  
 
Subjects will be recruited by posting flyers in designated areas around USU’s campus, through 
advertisements on social media. In the advertisement, potential subjects for this study will be directed to 
contact the study team by email or phone to obtain more information about the study, if interested. 
Participants who are interested will be provided with a copy of the informed consent by email. When the 
participant expresses interest in being in the study, the study team member will confirm by telephone 
that the participant meets most of the inclusion/exclusion criteria (ones that can be determined without 
Lab/Blood Work 
Screening 
Met Visit 1 Met Visit 2 
Met Visit 3 
Pregnancy test (hCG) 
X 
 
 
 
Insulin 
X 
 
 
 
Glucose 
X 
 
 
 
BMP 
X 
 
 
 
Lipid panel 
X 
 
 
 
HbA1C 
X 
 
 
 
Blood inflammatory markers 
 
X 
X 
X 
Urinary/plasma metabolomics 
 
X 
X 
X 

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the need for a blood draw) before scheduling him/her for a consent meeting. Subjects will attend a one-
on-one information session that will be conducted by trained member to present the details of the study. 
We anticipate that we will need to telephone screen, approximately 150 people and that approximately 45 
will be consented. We will enroll up to 30 participants to meet our goal of having at least 24 participants 
complete the study (assuming a 20 % drop-out rate). 
 
4.2 Compensation 
 
Participants will receive compensation for completing each study procedure for a maximum of 
$475, which will be paid at the end of the study. If a participant drops out of the study before completing 
the entire study, they will be paid according to the degree of completion. Participants will receive $25 
for the screening blood draw visit and $150 for each of the metabolic visits. 
  
5. RISK/BENEFIT ASSESSMENT 
 
This study provides no potential benefit to the participant other than the satisfaction of having 
contributed to the potential future benefit of others. Participants will be provided with their lab clinical 
results, which may be of interest to them. Society may benefit by having more information about the 
health effects of different types of meat, which may help inform consumer food choices. Participation in 
this study may lead to increased risk for the following: 
 
o Blood draws: Blood drawing can result in bruising, mild discomfort, and rarely, an infection 
where the needle enters the skin.  There also is a possibility of lightheadedness and fainting.  
Sterile techniques and the use of trained phlebotomists will minimize these risks. 
 
6. COSTS TO THE SUBJECT 
 
There will be no costs to participants for any of the treatments or testing done as part of this research 
study. Immediate necessary care is available if an individual is injured because of participation in a research 
project. However, there is no provision for free medical care or for monetary compensation for such injury. 
During this study, hospitalizations or additional care beyond the scope of this study will be the 
responsibility of patients and/or their insurance company. 
 
7. ANALYTICAL PROCEDURES AND STATISTICAL CONSIDERATIONS 
 
o Inflammation: Inflammatory biomarkers (IL-6, VCAM-1, TNF-alpha and C-reactive protein 
[CRP]) will be measured using ELISA kits at Dr. van Vliet’s laboratory at Utah State 
University. Plasma samples will be stored at -80ºC until cytokine analyses are performed. 
 
o Metabolomics: Mass spectrometry techniques will be used for untargeted and/or targeted 
assessment of blood and/or urinary metabolites. This analysis will give insight into the 
appearance of food-derived metabolites in the human body and how they may impact 
inflammatory responses after eating. This analysis will be performed using de-identified 
samples by Metabolon Inc (a company dedicated to metabolomics analysis) and/or the Plant 
for Human Health Institute. Samples will be provided to these core services as de-identified 
samples. No other data will be shared with these core services. Plasma and urine samples will 
be stored at -80ºC until metabolomics analyses are performed. 
 

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o Dietary logs: The Diet History Questionnaire III (NIH) and 3-day food records will be 
analyzed by dietetic staff within Dr. van Vliet’s laboratory at Utah State University. 
 
o Statistical analysis: Change scores (post-dietary intervention – baseline) will be created for all 
inflammatory biomarkers and metabolites. Metabolic intermediate data will be reduced into 
Metabolic Factors using Principal Component Analysis (PCA) of the change scores. Factor 
scores will be computed for each individual for both diets. Change scores and factor (change) 
scores for both diets will be compared using paired t-tests. P< 0.05 will be considered statistically 
significant and analyses will be performed in SAS 9.4 (SAS, Cary, NC).  
 
o Power Calculations: Using untargeted metabolomics for our power calculations of the number 
of participants we need to recruit, we assume a P-value ≤ 0.05, Q-value ≤ 0.3, and standard 
deviation of 0.3 based on previous work (Pimentel et al., 2018). Since there are no entirely 
comparable previous studies available to draw from, the effect size and number of truly different 
metabolites are meant to give general estimates. 600 metabolites are typically identified (Nieman 
et al., 2015) and conservative estimation is that 20-40 metabolites will be significantly different 
with a mean of 0.2624 (30% difference). An n=24 per group is expected to provide true discovery 
rates ranging from 89-93 % assuming differences in 80-120 metabolites. Assuming a drop-out 
of 20%, the final number of participants we will recruit is N=30. This, we consider adequate 
without having to engage more participants than necessary to address the research aims. 
 
8. DATA STORAGE AND CONFIDENTIALITY   
Clinical study data (including screening data, food logs, questionnaires, satiety responses, 
bloodwork) will be collected and managed using REDCap (Research Electronic Data Capture). REDCap 
is a secure web application designed to support data capture for research studies, providing user-friendly 
web-based case report forms, real-time data entry validation (e.g. for data types and range checks), audit 
trails and a participant coded data export mechanism to common statistical packages (SPSS, SAS, Stata, 
R/S-Plus). The system was developed by a multi-institutional consortium initiated at Vanderbilt 
University. REDCap servers are hosted in the College of Education & Human Services at Utah State 
University, where data will be stored and processed. REDCap data collection projects rely on a thorough 
study-specific data dictionary defined in an iterative self-documenting process by all members of the 
research team. This iterative development and testing process results in a well-planned data collection 
strategy for individual studies. REDCap is flexible enough to be used for a variety of types of research 
and provides an intuitive user interface for database design and data entry. Coded clinical data will be 
stored indefinitely on REDCap and/or USU’s Box. The enrollment log, with participant names/addresses 
that can be linked back to participant codes, which is kept on the Van Vliet Lab Shared Drive on USU's 
box will be destroyed 3 years after completing the study. It is anticipated that all manuscripts will be 
published at that time and have been sent to interested study participants. Online activity always carry 
with them a risk of breach. Participants will be made aware of these potential threats and risks to their 
confidentiality. 
Biospecimens will be stored in a -80ºC freezer at the Center for Human Nutrition Studies for the 
duration of sample collection. All samples will be stored using coded labels. Blood samples collected 
during screening will be sent to Labcorp for routine bloodwork. Once all biospecimens have been collected 
from all participants, all biospecimens will be transported to a -80ºC freezer in the Nutrition and Food 

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Science building for long-term storage (maximum of 20 years). Any participant coded analytical data 
(including inflammatory biomarkers, metabolomics data, and analyzed food log data) will be kept on the 
Van Vliet Lab Drive at USU’s Box Drive to be accessed only by Dr. Stephan van Vliet and his study staff. 
Study records that identify subjects will be kept confidential as required by law. Federal Privacy 
Regulations provide safeguards for privacy, security, and authorized access. Except when required by law, 
they will not be identified by name, social security number, address, telephone number, or any other direct 
personal identifier in study records disclosed outside of Utah State University. For records disclosed 
outside of USU, they will be assigned a code number. The key to the code will be kept on the Van Vliet 
Lab Drive at USU’s Box Drive. For participants that choose to withdraw from the study after biospecimens 
have been collected, they will have three years to instruct the research team on whether they’d like the 
unused identifiable blood and urine samples destroyed or if they would like the samples to be used for 
other research. After the three year time period, information samples will be de-identified and it will not 
be possible to know whose is whose.  
9. DATA SAFETY AND MONITORING   
All study members will have completed CITI- and other institutional training pertinent to the 
study. Any unanticipated problems will be reported to the USU IRB by the PI as per institutional policy. 
 
10. LITERATURE 
Baudry, J., Méjean, C., Allès, B., Péneau, S., Touvier, M., Hercberg, S., Lairon, D., Galan, P., and Kesse-Guyot, E. (2015). 
Contribution of Organic Food to the Diet in a Large Sample of French Adults (the NutriNet-Santé Cohort Study). 
Nutrients 7, 8615-8632. 
Holt, S., Brand Miller, J., Petocz, P., and Farmakalidis, E. (1995). A satiety index of common foods. European journal of 
clinical nutrition 49, 675-690. 
Lain, K.Y., and Catalano, P.M. (2007). Metabolic changes in pregnancy. Clin Obstet Gynecol 50, 938-948. 
Nieman, D.C., Gillitt, N.D., Sha, W., Meaney, M.P., John, C., Pappan, K.L., and Kinchen, J.M. (2015). Metabolomics-Based 
Analysis of Banana and Pear Ingestion on Exercise Performance and Recovery. Journal of Proteome Research 14, 
5367-5377. doi: 5310.1021/acs.jproteome.5365b00909. 
Pimentel, G., Burton, K.J., Von Ah, U., Butikofer, U., Pralong, F.P., Vionnet, N., Portmann, R., and Vergeres, G. (2018). 
Metabolic Footprinting of Fermented Milk Consumption in Serum of Healthy Men. J Nutr 148, 851-860.