Postprandial Effects of Animal Versus Plant-Based Protein

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06445296
Study type	Interventional
Source	Ball State University
Contact	Bryant Keirns, PhD
Phone	765-285-8356
Email	bryant.keirns@bsu.edu
Status	Recruiting
Phase	N/A
Start date	November 1, 2023
Completion date	December 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06013163` - A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT03843424` - Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers	N/A
Not yet recruiting	`NCT06360536` - Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women	N/A
Not yet recruiting	`NCT05997576` - A Study of TG103 Injection in Non-diabetic Overweight or Obesity	Phase 3
Recruiting	`NCT04763291` - Cardiovascular and InflammAging Study	N/A
Active, not recruiting	`NCT04399460` - The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control	N/A
Completed	`NCT04451824` - Examination of Circumferential Reduction	N/A
Completed	`NCT04110717` - Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight	N/A
Completed	`NCT05561855` - T2DM Intensity Lifestyle Intervention	N/A
Active, not recruiting	`NCT04100200` - Berries, Inflammation, and Gut Microbiome	N/A
Recruiting	`NCT06125964` - eMOTION Formative Study	N/A
Recruiting	`NCT06087822` - Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®	N/A
Active, not recruiting	`NCT04328233` - Impact of Time-Restricted Eating on Metabolic Homeostasis, Inflammation and Oxidative Stress in Metabolic Syndrome	N/A
Completed	`NCT06091761` - Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity	N/A
Completed	`NCT04894344` - Education to Decrease in Sodium Intake Evaluated With 24 Hour Urinary Sodium Excretion (RCT)	N/A
Completed	`NCT05713461` - Physical Exercise in Obesity for Health and Quality of Life.	N/A
Not yet recruiting	`NCT06054698` - Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects	Phase 2
Not yet recruiting	`NCT02823912` - Capsaicin Effect on Cytokines Profile in Dyslipidemia	Phase 2/Phase 3
Completed	`NCT05104151` - Efficacy of a Nutritive Bar, in Reduction of Weight, Body Fat and Control of Appetite	N/A
Completed	`NCT04786925` - Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.