InflammationNCT04034160
Beef Burger Versus a Vegetarian Burger
A study testing vegetarian burger and beef burger in people with Inflammation, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this graduate student research study is to compare the rise of serum lipids, glucose, and hs-CRP levels after consumption of a beef burger versus a vegetarian burger in healthy adults between the ages of 21 and 55 Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- vegetarian burger and beef burger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 28 Jan 2020
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between 21 and 55 years of age
- Consume both beef and vegetarian products
- No distaste for whole wheat buns, lettuce, soy, tomatoes, or vegan mayonnaise
- Willing to abstain from caffeine and exercise the morning of visits (2 days)
Who cannot join
- Those allergic to the following food items:
- Gluten
- Lettuce
- Soy
- Tomatoes
- Vegan Mayonnaise
- Have a known history of dyslipidemia, diabetes mellitus, or arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Rise of Serum Lipids, Glucose, and Hs-CRP Levels After Consumption of a Beef Burger Versus a Vegetarian Burger
The purpose of this graduate student research study is to compare the rise of serum lipids, glucose, and hs-CRP levels after consumption of a beef burger versus a vegetarian burger in healthy adults between the ages of 21 and 55
Read the detailed description
Visit 1
- Sign an informed consent.
- Complete a brief questionnaire about demographics (age, gender, and race), eating habits, physical activity level, and medical history (known allergies, and history of dyslipidemia, diabetes mellitus, or arthritis)
- Will be directed to fast for 8 hours prior to Visit 2. Visit 2
- Be randomized into either Group 1 or Group 2. One group will eat the beef burger first and the other group will eat the vegetarian burger first.
- Fill out a questionnaire on number of hours slept and current stress level.
- Take a finger prick test (tiny drop of blood) to determine baseline measurements for serum lipids, glucose, and hs-CRP levels.
- Consume either a beef burger or vegetarian burger.
- Afterwards, remain in Nichol Hall, Room A112, for 2 hours (may study, watch a movie, etc.).
- May not consume anything except for water.
- After 30 min, 60 min, 120 min, finger prick tests will be used to measure post-consumption serum lipids, glucose, and hs-CRP levels.
- Will be asked to try and identify burger consumed and rate the taste of the burger.
- Will be directed to fast for 8 hours prior to Visit 3. Visit 3
- Repeat the same procedure as Visit 2. However, this time the burgers will be switched.
- Conditions
- Inflammation
- Being tested
- vegetarian burger, beef burger
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vegetarian burgerOther
A finger prick test will be used to determine baseline levels measurements for serum lipids, glucose, and hs-CRP levels. Group 1 will be given vegetarian burgers to consume. Participants will need to remain in the room for 2 hours, postprandial (they may study, watch a movie, etc). They will not be allowed to consume anything except for water during this time. After consumption of burger, at 30 min, 60 min, 120 min, finger prick tests will be used to obtain blood. Participants will also be asked to try and identify the burger they consumed and rate the taste of the burger. Visit 2 will take approximately 3 hours.
- Participants will be directed to fast for 8 hours prior to Visit 3 (the following week).
- Visit 3: We will repeat the same procedure as Visit 2. However, this time the burgers will be switched.
beef burgerOther
A finger prick test will be used to determine baseline levels measurements for serum lipids, glucose, and hs-CRP levels. Group 2 will be given beef burgers to consume. Participants will need to remain in the room for 2 hours, postprandial (they may study, watch a movie, etc). They will not be allowed to consume anything except for water during this time. After consumption of burger, at 30 min, 60 min, 120 min, finger prick tests will be used to obtain blood. Participants will also be asked to try and identify the burger they consumed and rate the taste of the burger. Visit 2 will take approximately 3 hours.
- Participants will be directed to fast for 8 hours prior to Visit 3 (the following week).
- Visit 3: We will repeat the same procedure as Visit 2. However, this time the burgers will be switched.
| Study group | Role | What they receive |
|---|---|---|
| burger consumption group | Experimental | Each participant will consume a burger with a whole wheat bun, lettuce, tomatoes, and vegan mayonnaise (free of cholesterol) for one meal. The burger patty will be 4 ounces. The beef patty (Beef Patty Chuck) will be 80% lean and 20% fat. Receives: Other: vegetarian burger |
| vegetarian burger consumption group | Active comparator | Each participant will consume a burger with a whole wheat bun, lettuce, tomatoes, and vegan mayonnaise (free of cholesterol) for one meal. The burger patty will be 4 ounces. The vegetarian patty (Impossible Burger) will be 18% fat. Receives: Other: beef burger |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum lipid panel concentration
Finger prick tests (tiny drop of blood) will be used to measure serum lipids at baseline, and then at 30 minutes, 60 minutes, and 120 minutes postprandial to determine each participant's lipid profile.
Measured: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Secondary outcomes (2)
glucose blood concentration
Finger prick tests (tiny drop of blood) will be used to measure glucose at baseline, and then at 30 minutes, 60 minutes, and 120 minutes postprandial to determine each participant's lipid profile.
Measured: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
hs-CRP blood concentration
Finger prick tests (tiny drop of blood) will be used to measure hs-CRP at baseline, and then at 30 minutes, 60 minutes, and 120 minutes postprandial to determine each participant's lipid profile.
Measured: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Oct 2019
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Kosch, Loma Linda University
- Investigators
- Cindy Kosch, MS, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034160
- Sponsor's protocol ID
- 5190215
- Status last verified
- Jan 2020
- First submitted
- 19 Jul 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Rise of Serum Lipids, Glucose, and Hs-CRP Levels After Consumption of a Beef Burger Versus a Vegetarian Burger
- ClinicalTrials.gov ID
- NCT04034160
- Acronym / sponsor ID
- 5190215
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 26 Jul 2019 (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.
The purpose of this graduate student research study is to compare the rise of serum lipids, glucose, and hs-CRP levels after consumption of a beef burger versus a vegetarian burger in healthy adults between the ages of 21 and 55
Detailed description
Visit 1
- Sign an informed consent.
- Complete a brief questionnaire about demographics (age, gender, and race), eating habits, physical activity level, and medical history (known allergies, and history of dyslipidemia, diabetes mellitus, or arthritis)
- Will be directed to fast for 8 hours prior to Visit 2. Visit 2
- Be randomized into either Group 1 or Group 2. One group will eat the beef burger first and the other group will eat the vegetarian burger first.
- Fill out a questionnaire on number of hours slept and current stress level.
- Take a finger prick test (tiny drop of blood) to determine baseline measurements for serum lipids, glucose, and hs-CRP levels.
- Consume either a beef burger or vegetarian burger.
- Afterwards, remain in Nichol Hall, Room A112, for 2 hours (may study, watch a movie, etc.).
- May not consume anything except for water.
- After 30 min, 60 min, 120 min, finger prick tests will be used to measure post-consumption serum lipids, glucose, and hs-CRP levels.
- Will be asked to try and identify burger consumed and rate the taste of the burger.
- Will be directed to fast for 8 hours prior to Visit 3. Visit 3
- Repeat the same procedure as Visit 2. However, this time the burgers will be switched.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| burger consumption group | Experimental | Other: vegetarian burgerEach participant will consume a burger with a whole wheat bun, lettuce, tomatoes, and vegan mayonnaise (free of cholesterol) for one meal. The burger patty will be 4 ounces. The beef patty (Beef Patty Chuck) will be 80% lean and 20% fat. |
| vegetarian burger consumption group | Active comparator | Other: beef burgerEach participant will consume a burger with a whole wheat bun, lettuce, tomatoes, and vegan mayonnaise (free of cholesterol) for one meal. The burger patty will be 4 ounces. The vegetarian patty (Impossible Burger) will be 18% fat. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults between 21 and 55 years of age
- Consume both beef and vegetarian products
- No distaste for whole wheat buns, lettuce, soy, tomatoes, or vegan mayonnaise
- Willing to abstain from caffeine and exercise the morning of visits (2 days)
Key exclusion criteria (7 listed)
- Those allergic to the following food items:
- Have a known history of dyslipidemia, diabetes mellitus, or arthritis
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 |
|---|---|---|
| vegetarian burgerA finger prick test will be used to determine baseline levels measurements for serum lipids, glucose, and hs-CRP levels. Group 1 will be given vegetarian burgers to consume. Participants will need to remain in the room for 2 hours, postprandial (they may study, watch a movie, etc). They will not be allowed to consume anything except for water during this time. After consumption of burger, at 30 min, 60 min, 120 min, finger prick tests will be used to obtain blood. Participants will also be asked to try and identify the burger they consumed and rate the taste of the burger. Visit 2 will take approximately 3 hours. * Participants will be directed to fast for 8 hours prior to Visit 3 (the following week). * Visit 3: We will repeat the same procedure as Visit 2. However, this time the burgers will be switched. | Other | burger consumption group |
| beef burgerA finger prick test will be used to determine baseline levels measurements for serum lipids, glucose, and hs-CRP levels. Group 2 will be given beef burgers to consume. Participants will need to remain in the room for 2 hours, postprandial (they may study, watch a movie, etc). They will not be allowed to consume anything except for water during this time. After consumption of burger, at 30 min, 60 min, 120 min, finger prick tests will be used to obtain blood. Participants will also be asked to try and identify the burger they consumed and rate the taste of the burger. Visit 2 will take approximately 3 hours. * Participants will be directed to fast for 8 hours prior to Visit 3 (the following week). * Visit 3: We will repeat the same procedure as Visit 2. However, this time the burgers will be switched. | Other | vegetarian burger consumption group |
Primary outcome
serum lipid panel concentration
Time frame: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Finger prick tests (tiny drop of blood) will be used to measure serum lipids at baseline, and then at 30 minutes, 60 minutes, and 120 minutes postprandial to determine each participant's lipid profile.
2 secondary outcomes
glucose blood concentration
Time frame: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
hs-CRP blood concentration
Time frame: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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.
Cindy Kosch, MS principal investigator
Loma Linda 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 vegetarian burger and beef burger in people with Inflammation, run by Loma Linda 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum lipid panel concentration (time frame: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2020.