Postprandial Effects of Animal Versus Plant-Based Protein

Overweight or Obesity Clinical Trial

Official title:

Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445296
• Other study ID #: 2103201
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Ball State University
• Contact: Bryant Keirns, PhD
• Phone: 765-285-8356
• Email: bryant.keirns[@]bsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Other:
• High-fat meal containing beef
High-fat meal (eggs cooked in butter, croissant) with 80% ground beef.
• High-fat meal containing Beyond Meat
High-fat meal (eggs cooked in butter, croissant) with Beyond Meat Cookout Classic.

Locations

Country	Name	City	State
United States	Health Professions Building, Ball State University	Muncie	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ball State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition	The investigators will measure body composition using bioelectrical impedance (InBody).	Through study completion, up to 1 year.
Other	Systolic and diastolic pressure	The investigators will measure blood pressure using an automated cuff (Omron).	Through study completion, up to 1 year.
Primary	Serum interleukin (IL)-6	The investigators will measure serum IL-6 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.	Through study completion, up to 1 year.
Primary	Serum lipopolysaccharide binding protein (LBP)	The investigators will measure serum LBP at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.	Through study completion, up to 1 year.
Primary	Serum soluble CD14 (sCD14)	The investigators will measure serum sCD14 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.	Through study completion, up to 1 year.
Primary	Serum lipopolysaccharide	The investigators will measure serum lipopolysaccharide at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.	Through study completion, up to 1 year.
Primary	Serum tumor necrosis factor (TNF)-alpha	The investigators will measure serum (TNF)-alpha at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.	Through study completion, up to 1 year.
Secondary	Triglycerides	The investigators will measure triglycerides at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion.	Through study completion, up to 1 year.
Secondary	HDL-C	The investigators will measure HDL-C at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion.	Through study completion, up to 1 year.
Secondary	Glucose	The investigators will measure glucose at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion.	Through study completion, up to 1 year.