Clinical trial NCT06445296: Postprandial Effects of Animal Versus Plant-Based Protein
Official title: Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Keywords: Plant-based meat alternatives
Lead sponsor: Ball State University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Serum interleukin (IL)-6
timeFrame: Through study completion, up to 1 year.
measure: Serum lipopolysaccharide binding protein (LBP)
timeFrame: Through study completion, up to 1 year.
measure: Serum soluble CD14 (sCD14)
timeFrame: Through study completion, up to 1 year.
measure: Serum lipopolysaccharide
timeFrame: Through study completion, up to 1 year.
measure: Serum tumor necrosis factor (TNF)-alpha
timeFrame: Through study completion, up to 1 year.
Secondary outcomes:
measure: Triglycerides
timeFrame: Through study completion, up to 1 year.
measure: HDL-C
timeFrame: Through study completion, up to 1 year.
measure: Glucose
timeFrame: Through study completion, up to 1 year.
Other outcomes:
measure: Body composition
timeFrame: Through study completion, up to 1 year.
measure: Systolic and diastolic pressure
timeFrame: Through study completion, up to 1 year.
Locations:
city: Muncie
country: United States
facility: Health Professions Building, Ball State University
state: Indiana
Study officials:
affiliation: Ball State University
name: Bryant Keirns
role: PRINCIPAL_INVESTIGATOR
References: