Beef Burger Versus a Vegetarian Burger
A Comparison of the Rise of Serum Lipids, Glucose, and Hs-CRP Levels After Consumption of a Beef Burger Versus a Vegetarian Burger
1 other identifier
interventional
35
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2020
CompletedJanuary 30, 2020
January 1, 2020
4 months
July 19, 2019
January 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
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
change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Study Arms (2)
burger consumption group
EXPERIMENTALEach 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 COMPARATOREach 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Those allergic to the following food items:
- Gluten
- Lettuce
- Soy
- Tomatoes
- Vegan Mayonnaise
- Have a known history of dyslipidemia, diabetes mellitus, or arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University
Loma Linda, California, 92350, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cindy Kosch, MS
Loma Linda University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair and Program Director, Department of Nutrition and Dietetics, School of Allied Health Professionals
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 26, 2019
Study Start
October 1, 2019
Primary Completion
January 28, 2020
Study Completion
January 28, 2020
Last Updated
January 30, 2020
Record last verified: 2020-01