Trials / Recruiting
RecruitingNCT06445296
Postprandial Effects of Animal Versus Plant-Based Protein
Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Ball State University · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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 (i.e., Beyond Meat) versus a comparable beef product within the context of high-fat, "Western-style" meal (i.e., eggs, meat, refined bread product). The investigators will also examine whether these responses differ based on whether individuals have a normal-weight or have overweight/obesity.
Detailed description
The investigators will recruit individuals with a BMI in the normal (18.5-24.9 kg/m2) or overweight/ obesity (\>25.0 kg/m2) 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 (i.e., 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 (e.g., IL-6) and intestinal permeability (e.g., lipopolysaccharide binding protein) using commercially available ELISAs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | High-fat meal containing beef | High-fat meal (eggs cooked in butter, croissant) with 80% ground beef. |
| OTHER | High-fat meal containing Beyond Meat | High-fat meal (eggs cooked in butter, croissant) with Beyond Meat Cookout Classic. |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2024-08-01
- Completion
- 2024-12-01
- First posted
- 2024-06-06
- Last updated
- 2024-06-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06445296. Inclusion in this directory is not an endorsement.