Overweight or ObesityNCT06445296
Postprandial Effects of Animal Versus Plant-Based Protein
A study testing High-fat meal containing beef and High-fat meal containing Beyond Meat in people with Overweight or Obesity, run by Ball State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- High-fat meal containing beef and High-fat meal containing Beyond Meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Health Professions Building, Ball State University
Muncie, Indiana, 47306
Bryant Keirns, PhD, 765-285-8356, bryant.keirns@bsu.edu
About this study
Official title: Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors
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.
Read the 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.
- Conditions
- Overweight or Obesity
- Being tested
- High-fat meal containing beef, High-fat meal containing Beyond Meat
- Keywords
- Plant-based meat alternatives
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat meal containing beefOther
High-fat meal (eggs cooked in butter, croissant) with 80% ground beef.
High-fat meal containing Beyond MeatOther
High-fat meal (eggs cooked in butter, croissant) with Beyond Meat Cookout Classic.
| Study group | Role | What they receive |
|---|---|---|
| Meal Consumption with Beyond Meat | Experimental | During the Beyond Meat arm, participants will consume a high-fat meal containing Beyond Meat (rather than beef). Meals will be otherwise identical. Receives: Other: High-fat meal containing Beyond Meat |
| Meal Consumption with Beef | Active comparator | During the Beef arm, participants will consume a high-fat meal containing beef (rather than Beyond Meat). Meals will be otherwise identical. Receives: Other: High-fat meal containing beef |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum interleukin (IL)-6
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.
Measured: Through study completion, up to 1 year.
Serum lipopolysaccharide binding protein (LBP)
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.
Measured: Through study completion, up to 1 year.
Serum soluble CD14 (sCD14)
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.
Measured: Through study completion, up to 1 year.
Serum lipopolysaccharide
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.
Measured: Through study completion, up to 1 year.
Serum tumor necrosis factor (TNF)-alpha
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.
Measured: Through study completion, up to 1 year.
Secondary outcomes (3)
Triglycerides
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.
Measured: Through study completion, up to 1 year.
HDL-C
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.
Measured: Through study completion, up to 1 year.
Glucose
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.
Measured: Through study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Nov 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryant Keirns, Principal investigator, Ball State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445296
- Sponsor's protocol ID
- 2103201
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fruit S, Keirns N, Higgins M, Quirk A, Schifferer J, Romanovich O, Yakos A, Osborne K, Trappe S, Keirns BH. Acute effects of a reformulated plant-based meat alternative compared to beef within a high-fat meal on inflammatory and metabolic factors: a randomized crossover trial. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0498.
PubMed 40127469
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors
- ClinicalTrials.gov ID
- NCT06445296
- Acronym / sponsor ID
- 2103201
- Conditions
- Overweight or Obesity
- Keywords
- Plant-based meat alternatives
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal Consumption with Beyond Meat | Experimental | Other: High-fat meal containing Beyond MeatDuring the Beyond Meat arm, participants will consume a high-fat meal containing Beyond Meat (rather than beef). Meals will be otherwise identical. |
| Meal Consumption with Beef | Active comparator | Other: High-fat meal containing beefDuring the Beef arm, participants will consume a high-fat meal containing beef (rather than Beyond Meat). Meals will be otherwise identical. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18 - 50 years.
- Body mass index > 18.5 kg/m2
- Not pregnant (females only)
- Not postmenopausal (females only).
- Not been diagnosed with cardiovascular disease.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat meal containing beefHigh-fat meal (eggs cooked in butter, croissant) with 80% ground beef. | Other | Meal Consumption with Beef |
| High-fat meal containing Beyond MeatHigh-fat meal (eggs cooked in butter, croissant) with Beyond Meat Cookout Classic. | Other | Meal Consumption with Beyond Meat |
Primary outcome
Serum interleukin (IL)-6
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Serum tumor necrosis factor (TNF)-alpha
Time frame: 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.
3 secondary outcomes
Triglycerides
Time frame: Through study completion, up to 1 year.
HDL-C
Time frame: Through study completion, up to 1 year.
Glucose
Time frame: Through study completion, up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Derived from this study: PubMed 40127469Fruit S, Keirns N, Higgins M, Quirk A, Schifferer J, Romanovich O, Yakos A, Osborne K, Trappe S, Keirns BH. Acute effects of a reformulated plant-based meat alternative compared to beef within a high-fat meal on inflammatory and metabolic factors: a randomized crossover trial. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0498.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryant Keirns principal investigator
Ball State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat meal containing beef and High-fat meal containing Beyond Meat in people with Overweight or Obesity, run by Ball State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bryant Keirns, PhD (765-285-8356, bryant.keirns@bsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum interleukin (IL)-6 (time frame: Through study completion, up to 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.