Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784806
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2021-03-03
Brief Title:
Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives
Status:
COMPLETED
Status Verified Date:
2022-01
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 the study is to quantify and compare the serum amino acid profile and muscle protein synthesis rates in response to consuming isonitrogenous amounts of ground meat beef and pork or plant-based alternatives -soy and pea protein-based patties
Specific aim 1 Describe the post-prandial amino acid profile in serum in the 3 hours following consumption of the following four burger patties in quantities calculated to deliver 20 grams of protein ground beef ground pork Beyond Meat burger and tofu burger
Specific aim 2 Compare the ability of these four different foods to activate mTORC1 and protein synthesis in muscle
Specific aim 1 Describe the post-prandial amino acid profile in serum in the 3 hours following consumption of the following four burger patties in quantities calculated to deliver 20 grams of protein ground beef ground pork Beyond Meat burger and tofu burger
Specific aim 2 Compare the ability of these four different foods to activate mTORC1 and protein synthesis in muscle
Detailed Description:
Study design
The first visit will be a brief meeting conducted over Zoom with one of the investigators Karine Schaal who will go over the study details with the volunteer answer their questions and obtain informed consent Subjects will sign the informed consent electronically using DocuSign Subjects will be given a copy of their signed informed consent form A paper copy of the consent form will be kept in a locked file cabinet in the office of the principal investigator
Study volunteers will come to the CTSC Clinical Research Center CCRC on four separate occasions The CCRC is located in the Cypress Building adjacent to the UC Davis Medical Center 2221 Stockton Blvd Suite D Sacramento CA 95817
The four study visits will be test visits scheduled over a two week period ie twice per week for 2 weeks at the same time in the morning following and overnight 12 hour fast They will be asked to refrain from vigorous exercise caffeine nicotine and alcohol for 24 hours prior to each visit Female volunteers will be asked to schedule their study visits within the first two weeks of their menstrual cycle starting on the first day of menstrual bleeding in order to control for ovarian hormone fluctuations which may impact digestion and metabolism
Upon arrival to the CCRC on the first test visit each volunteers height and weight will be measured
I Baseline blood draw Subjects will then be placed in individual testing rooms equipped with a reclining phlebotomy armchair A registered nurse or nurse practitioner will insert a 22G catheter in a forearm vein and an initial 35 mL baseline blood sample will be collected
II Test meal
After the baseline blood sample is collected subjects will consume one of the following four burgers in isonitrogenous amounts to deliver 20 g of protein
106g ground beef patty 85 lean 15 fat
118g ground pork 725 lean 275 fat
113g Beyond Meat patty
113g tofu patty
Each food will be weighed before cooking The beef pork and Beyond burgers will be grilled on an indoor electric grill until internal temperature reaches 165F to comply with the USDA Recommendations for Food Safety beef and pork minimum 160F and manufacturer instructions Beyond Meat Tofu burgers are pre-cooked and will be warmed by grilling for 2 minutes per manufacturer recommendations The internal temperature of the burgers will be monitored using a meat thermometer The burgers will be served to the volunteers as soon as they are finished cooking
Subjects will be asked to consume each patty without buns or condiments within a 10 minute period and instructed to chew thoroughly They will also be asked to drink a 6 ounce glass of water with the meal
III Postprandial blood draws
Following consumption of the test meal the participants will remain at the research site in their individual testing room for another 3 hours sitting quietly - they may bring books or electronic devices to pass the time Five more blood samples of 35 mL each will be obtained at 30 60 90 120 and 180 minutes after the test meal totaling six blood draws of 35mL per visit 21mL per visit and 84 mL of blood drawn in total for each subject completing the entire study
Blood will be collected in 35 mL serum separating tubes Approximately 50 microliters of whole-blood will be used to measure blood glucose within 5 minutes of the draw The rest will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutesThe serum will be frozen and kept at -80C until processed 100 microliters of each serum sample will be used for determining amino acid concentrations by high performance liquid chromatography HPLC at the UC Davis Proteomics Core Another 100 microliters will be used to measure insulin concentrations via enzyme-linked immunoassay The rest of the serum will be used for developing the mTORC1 bioassay
The order in which subjects receive each test meal will be randomized to avoid any order effect and at least a two-day washout period will be given between visits
The first visit will be a brief meeting conducted over Zoom with one of the investigators Karine Schaal who will go over the study details with the volunteer answer their questions and obtain informed consent Subjects will sign the informed consent electronically using DocuSign Subjects will be given a copy of their signed informed consent form A paper copy of the consent form will be kept in a locked file cabinet in the office of the principal investigator
Study volunteers will come to the CTSC Clinical Research Center CCRC on four separate occasions The CCRC is located in the Cypress Building adjacent to the UC Davis Medical Center 2221 Stockton Blvd Suite D Sacramento CA 95817
The four study visits will be test visits scheduled over a two week period ie twice per week for 2 weeks at the same time in the morning following and overnight 12 hour fast They will be asked to refrain from vigorous exercise caffeine nicotine and alcohol for 24 hours prior to each visit Female volunteers will be asked to schedule their study visits within the first two weeks of their menstrual cycle starting on the first day of menstrual bleeding in order to control for ovarian hormone fluctuations which may impact digestion and metabolism
Upon arrival to the CCRC on the first test visit each volunteers height and weight will be measured
I Baseline blood draw Subjects will then be placed in individual testing rooms equipped with a reclining phlebotomy armchair A registered nurse or nurse practitioner will insert a 22G catheter in a forearm vein and an initial 35 mL baseline blood sample will be collected
II Test meal
After the baseline blood sample is collected subjects will consume one of the following four burgers in isonitrogenous amounts to deliver 20 g of protein
106g ground beef patty 85 lean 15 fat
118g ground pork 725 lean 275 fat
113g Beyond Meat patty
113g tofu patty
Each food will be weighed before cooking The beef pork and Beyond burgers will be grilled on an indoor electric grill until internal temperature reaches 165F to comply with the USDA Recommendations for Food Safety beef and pork minimum 160F and manufacturer instructions Beyond Meat Tofu burgers are pre-cooked and will be warmed by grilling for 2 minutes per manufacturer recommendations The internal temperature of the burgers will be monitored using a meat thermometer The burgers will be served to the volunteers as soon as they are finished cooking
Subjects will be asked to consume each patty without buns or condiments within a 10 minute period and instructed to chew thoroughly They will also be asked to drink a 6 ounce glass of water with the meal
III Postprandial blood draws
Following consumption of the test meal the participants will remain at the research site in their individual testing room for another 3 hours sitting quietly - they may bring books or electronic devices to pass the time Five more blood samples of 35 mL each will be obtained at 30 60 90 120 and 180 minutes after the test meal totaling six blood draws of 35mL per visit 21mL per visit and 84 mL of blood drawn in total for each subject completing the entire study
Blood will be collected in 35 mL serum separating tubes Approximately 50 microliters of whole-blood will be used to measure blood glucose within 5 minutes of the draw The rest will be allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutesThe serum will be frozen and kept at -80C until processed 100 microliters of each serum sample will be used for determining amino acid concentrations by high performance liquid chromatography HPLC at the UC Davis Proteomics Core Another 100 microliters will be used to measure insulin concentrations via enzyme-linked immunoassay The rest of the serum will be used for developing the mTORC1 bioassay
The order in which subjects receive each test meal will be randomized to avoid any order effect and at least a two-day washout period will be given between visits
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