Postprandial Effects of Animal Versus Plant-Based Protein

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lipoprotein Effects of Substituting Beef Protein for Carbohydrate

NCT00852267

Healthy Cardiovascular Disease Atherogenic Dyslipidemia

COMPLETED NA

Plant-Based Meat Analogues and Human Health

NCT07031752

Satiation, Satiety Insulin Glucose +4 more

COMPLETED NA

Low Fat Plant-Based Supplemented Diet Effects on Risk Factors for Chronic Non-communicable Diseases

NCT02905448

Hyperlipidemia Metabolic Syndrome X

COMPLETED NA

Effects of Proportioning Meat and Plant-based Protein-rich Foods on Cardiovascular Disease Risk Factors (S58)

NCT04820829

Healthy Diet Cardiovascular Risk Factor

COMPLETED NA

Impact of Reducing Dietary Intake of Red and Processed Meat Intake on Fasting Lipemia in Healthy Participants

NCT02907112

Lipidemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight or Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

High-fat meal containing Beyond Meat

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

High-fat meal containing beef

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-fat meal containing beef

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

Intervention Type OTHER

High-fat meal containing Beyond Meat

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes