Recruiting

Animal & Plant-Based

Sponsor:

Ball State University

Code:

NCT06445296

Conditions

Overweight or Obesity

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

High-fat meal containing beef

High-fat meal containing Beyond Meat

Study Details

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

Study ID

NCT06445296

Start date

Nov 1, 2023

Status verified date

May, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Aug 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Meal Consumption with Beyond Meat

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

active comparator: Meal Consumption with Beef

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

Interventions

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.

Primary outcome measure

  • Serum interleukin (IL)-6 [ Time Frame: Through study completion, up to 1 year. ]
  • Serum lipopolysaccharide binding protein (LBP) [ Time Frame: Through study completion, up to 1 year. ]
  • Serum soluble CD14 (sCD14) [ Time Frame: Through study completion, up to 1 year. ]
  • Serum lipopolysaccharide [ Time Frame: Through study completion, up to 1 year. ]
  • Serum tumor necrosis factor (TNF)-alpha [ Time Frame: Through study completion, up to 1 year. ]

Central Contacts and Locations

Central contacts

Bryant Keirns, PhD

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

Locations

Health Professions Building, Ball State University

Recruiting

Muncie, Indiana, United States, 47306

Contacts

Bryant Keirns, PhD

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

More Information

Sponsor

Ball State University

Last update posted

Jun 6, 2024

Last verified

May, 2024

Keywords

  • Plant-based meat alternatives

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ball State University on 2024-06-06.