Postprandial Effects of Animal Versus Plant-Based Protein

NCT06445296 | Recruiting DMC

• 1 other identifier: 2103201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Overweight or Obesity

Keywords

Plant-based meat alternatives

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Triglycerides

  Through study completion, up to 1 year.

• HDL-C

  Through study completion, up to 1 year.

• Glucose

  Through study completion, up to 1 year.

Other Outcomes (2)

• Body composition

  Through study completion, up to 1 year.

• Systolic and diastolic pressure

  Through study completion, up to 1 year.

Study Arms (2)

Meal Consumption with Beyond Meat

EXPERIMENTAL

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

Other: High-fat meal containing Beyond Meat

Meal Consumption with Beef

ACTIVE COMPARATOR

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

Other: High-fat meal containing beef

Interventions

High-fat meal containing beef OTHER

High-fat meal (eggs cooked in butter, croissant) with 80% ground beef.

Meal Consumption with Beef

High-fat meal containing Beyond Meat OTHER

High-fat meal (eggs cooked in butter, croissant) with Beyond Meat Cookout Classic.

Meal Consumption with Beyond Meat

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ball State University: lead

Study Sites (1)

Health Professions Building, Ball State University

Muncie, Indiana, 47306, United States

RECRUITING

Related Publications (1)

• Fruit S, Keirns N, Higgins M, Quirk A, Schifferer J, Romanovich O, Yakos A, Osborne K, Trappe S, Keirns BH. Acute effects of a reformulated plant-based meat alternative compared to beef within a high-fat meal on inflammatory and metabolic factors: a randomized crossover trial. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0498.

  PMID: 40127469 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryant Keirns

  Ball State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryant Keirns, PhD

CONTACT

765-285-8356; bryant.keirns@bsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: While complete blinding is not possible (participants will see/taste the food they eat), the investigators will not tell participants whether they are consuming beef or Beyond Meat.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: June 6, 2024
• Study Start: November 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)