Postprandial Effects of Animal Versus Plant-Based Protein

Ball State University

Status: Enrolling

Conditions: Overweight or Obesity

Treatments: Other: High-fat meal containing Beyond Meat; Other: High-fat meal containing beef

Study type: Interventional

Funder types: Other

Identifiers

NCT06445296

2103201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 - 50 years.
• Body mass index > 18.5 kg/m2
• Not pregnant (females only)
• Not postmenopausal (females only).
• Not been diagnosed with cardiovascular disease.
• Not been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
• Not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
• Does not regularly take anti-inflammatory drugs (more than 2x week).
• Does not use glucose-lowering drugs (e.g., metformin)
• Does not use lipid-lowering drugs (e.g., statins)
• Does not use tobacco products or any illicit drugs.
• Does not have a pacemaker.
• Can consume pea products (Beyond Meat is made from pea protein).

Exclusion criteria

• Not between the ages of 18-50
• Body mass index < 18.5 kg/m2
• Pregnant (females only)
• Postmenopausal status (females only).
• Been diagnosed with cardiovascular disease.
• Been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
• Been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
• Regularly take anti-inflammatory drugs (more than 2x week).
• Uses glucose-lowering drugs (e.g., metformin)
• Uses lipid-lowering drugs (e.g., statins)
• Uses tobacco products or any illicit drugs.
• Have a pacemaker.
• Allergic to pea products (Beyond Meat is made from pea protein).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Meal Consumption with Beyond Meat

Experimental group

Description:

During the Beyond Meat arm, participants will consume a high-fat meal containing Beyond Meat (rather than beef). Meals will be otherwise identical.

Treatment:

Other: High-fat meal containing Beyond Meat

Meal Consumption with Beef

Active Comparator group

Description:

During the Beef arm, participants will consume a high-fat meal containing beef (rather than Beyond Meat). Meals will be otherwise identical.

Treatment:

Other: High-fat meal containing beef