Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2022-12-19
Brief Title:
Beef and Plant Burger Metabolomics Study
Sponsor:
Utah State University
Organization:
Utah State University
Study Overview
Official Title:
Effects of Different Sources of Beef and Plant-based Meat Alternatives on Postprandial Inflammatory and Metabolic Profiles of Consumers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of meat on inflammatory and metabolite profiles in middle-aged individuals after an acute meal Up to 36 adults who are overweight or obese and between 30-60 years old will undergo a consentscreening visit followed by three study visits On separate visits to the clinical research facilities at the Center for Human Nutrition Studies participants will consume either 9 oz 250 grams of cooked grain-fed beef grass-fed beef or a plant-based meat alternative Impossible Burger Blood will be drawn prior to food consumption and three more times after eating the meal at 1h 3h and 5h after participants finishing their meal The investigators will use those blood samples to determine the impacts of these foods on inflammatory markers and metabolite profiles compounds that circulate in our blood such as amino acids fatty acids and phenolics
Detailed Description:
BACKGROUND
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
STUDY OBJECTIVES
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
To determine effects on plasma metabolites vitamin and mineral derivatives polyphenols amino acids etc collected through regular blood sampling during the 300 min postprandial phase at 60 min 180 min and 300 min
To determine the effects on subjective satiety at 15 30 60 min and every hour thereafter following consumption
DESIGN AND PROCEDURES
Participants will be asked to complete one screeningconsent 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 at Utah State University
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 inclusionexclusion 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 consentscreening visit The pre-screen is put in place to confirm that the participant meets most of the inclusionexclusion 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 consentedscreened 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 consentscreening 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 The investigators 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 The investigators ask participants to come in during the morning after an overnight 12-hour fast During this visit the following procedures will be performed
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 participants 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
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 m2
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
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
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 subjects 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 15 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 workreador watch entertainment on their own electronic device Participants will be allowed to get up and use the rest-room however the investigators will ask participants to remain sedentary otherwise
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 The investigators 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 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
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
Satiety Scale Participants are asked to mark a validated satiety scale at 30 60 90 120 min and every hour thereafter until 300 min to assess subjective satiety after meat consumption
Dietary and activity control The investigators will ask participants to maintain their habitual diet physical activity and sleep levelsTThe investigators will ask participants to fill in 3-day dietary and sleep logs for the three days prior to their metabolic visit see attachments The investigators 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 the investigators 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
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
STUDY OBJECTIVES
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
To determine effects on plasma metabolites vitamin and mineral derivatives polyphenols amino acids etc collected through regular blood sampling during the 300 min postprandial phase at 60 min 180 min and 300 min
To determine the effects on subjective satiety at 15 30 60 min and every hour thereafter following consumption
DESIGN AND PROCEDURES
Participants will be asked to complete one screeningconsent 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 at Utah State University
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 inclusionexclusion 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 consentscreening visit The pre-screen is put in place to confirm that the participant meets most of the inclusionexclusion 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 consentedscreened 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 consentscreening 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 The investigators 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 The investigators ask participants to come in during the morning after an overnight 12-hour fast During this visit the following procedures will be performed
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 participants 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
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 m2
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
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
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 subjects 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 15 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 workreador watch entertainment on their own electronic device Participants will be allowed to get up and use the rest-room however the investigators will ask participants to remain sedentary otherwise
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 The investigators 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 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
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
Satiety Scale Participants are asked to mark a validated satiety scale at 30 60 90 120 min and every hour thereafter until 300 min to assess subjective satiety after meat consumption
Dietary and activity control The investigators will ask participants to maintain their habitual diet physical activity and sleep levelsTThe investigators will ask participants to fill in 3-day dietary and sleep logs for the three days prior to their metabolic visit see attachments The investigators 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 the investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None