Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445296
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-04-26
Brief Title:
Postprandial Effects of Animal Versus Plant-Based Protein
Sponsor:
Ball State University
Organization:
Ball State University
Study Overview
Official Title:
Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Shifting away from diets high in animal products towards more plant predominant diets is recommended by many health organizations to both reduce the negative environmental impacts of animal agriculture and to improve health outcomes As a result a number of plant-based meat alternatives such as Beyond Meat have been formulated to promote increased plant consumption However evidence is limited on the impact of newer plant-based meat alternatives on common cardiometabolic risk factors The investigators aim to compare the acute metabolic gastrointestinal and inflammatory effects of a plant-based meat alternative ie Beyond Meat versus a comparable beef product within the context of high-fat Western-style meal ie eggs meat refined bread product The investigators will also examine whether these responses differ based on whether individuals have a normal-weight or have overweightobesity
Detailed Description:
The investigators will recruit individuals with a BMI in the normal 185-249 kgm2 or overweight obesity 250 kgm2 ranges from the Ball State University campus and surrounding communities Each participant will complete two meal trials in a randomized crossover design At each meal trial a intravenous catheter will be inserted and baseline blood sample collected Next participants will consume a high-fat Western style meal consisting of eggs cooked in butter a croissant and either 4 oz of 80 ground beef or 4 oz of Beyond Meat Cookout Classic variety The Beyond Meat and beef products have nearly identical macronutrient profiles allowing for examination of the unique properties of the two protein sources Regardless of primary protein source beef or Beyond Meat each meal will contain 980 calories 60g fat Following completion of each meal blood samples will also be collected 1- 2- 3- and 4-hours The investigators will measure metabolic markers ie triglycerides glucose HDL-C immediately upon sample collection using the Piccolo Xpress clinical chemistry analyzer Additional blood will be collected and stored as serum in order to measure indicators of inflammation eg IL-6 and intestinal permeability eg lipopolysaccharide binding protein using commercially available ELISAs
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