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

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

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Other: vegetarian burger; Other: beef burger

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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)

Exclusion criteria:

• Those allergic to the following food items:

  • Gluten
  • Lettuce
  • Soy
  • Tomatoes
  • Vegan Mayonnaise
• Have a known history of dyslipidemia, diabetes mellitus, or arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: burger consumption group; 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.	Other: vegetarian burger; 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.
Active Comparator: vegetarian burger consumption group; 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.	Other: beef burger; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Cindy Kosch, MS, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): January 28, 2020

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 5190215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No