Postprandial Effects of Animal Versus Plant-Based Protein

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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 Start (Actual) 1 November 2023

🗓️ Primary Completion (Estimated) 1 August 2024

✅ Study Completion (Estimated) 1 December 2024

👥 Enrollment (Estimated) 30

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Muncie, Indiana, United States

📋 Eligibility Criteria

Description

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).

Ages Eligible for Study: 18 Years to 50 Years (ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 26 April 2024
First Submitted that Met QC Criteria 31 May 2024
First Posted 6 June 2024

Study Record Updates

Last Update Submitted that Met QC Criteria 31 May 2024
Last Update Posted 6 June 2024
Last Verified May 2024