Overweight or Obesity
Conditions
Keywords
Plant-based meat alternatives
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.
Interventions
OTHERHigh-fat meal containing beef
High-fat meal (eggs cooked in butter, croissant) with 80% ground beef.
OTHERHigh-fat meal containing Beyond Meat
High-fat meal (eggs cooked in butter, croissant) with Beyond Meat Cookout Classic.
Sponsors
Ball State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum tumor necrosis factor (TNF)-alpha | Through study completion, up to 1 year. | The investigators will measure serum (TNF)-alpha at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion. |
| Serum interleukin (IL)-6 | Through study completion, up to 1 year. | The investigators will measure serum IL-6 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion. |
| Serum lipopolysaccharide binding protein (LBP) | Through study completion, up to 1 year. | The investigators will measure serum LBP at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion. |
| Serum soluble CD14 (sCD14) | Through study completion, up to 1 year. | The investigators will measure serum sCD14 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion. |
| Serum lipopolysaccharide | Through study completion, up to 1 year. | The investigators will measure serum lipopolysaccharide at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | Through study completion, up to 1 year. | The investigators will measure triglycerides at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion. |
| HDL-C | Through study completion, up to 1 year. | The investigators will measure HDL-C at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion. |
| Glucose | Through study completion, up to 1 year. | The investigators will measure glucose at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body composition | Through study completion, up to 1 year. | The investigators will measure body composition using bioelectrical impedance (InBody). |
| Systolic and diastolic pressure | Through study completion, up to 1 year. | The investigators will measure blood pressure using an automated cuff (Omron). |
Countries
United States
Contacts
Primary ContactBryant Keirns, PhD
Outcome results
None listed