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Beef Burger Versus a Vegetarian Burger

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vegetarian burger
beef burger
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammation

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

burger consumption group

vegetarian burger consumption group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 19, 2019
Last Updated
January 28, 2020
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT04034160
Brief Title
Beef Burger Versus a Vegetarian Burger
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
January 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
burger consumption group
Arm Type
Experimental
Arm Description
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.
Arm Title
vegetarian burger consumption group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
vegetarian burger
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
beef burger
Intervention Description
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.
Primary Outcome Measure Information:
Title
serum lipid panel concentration
Description
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.
Time Frame
change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Secondary Outcome Measure Information:
Title
glucose blood concentration
Description
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.
Time Frame
change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Title
hs-CRP blood concentration
Description
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.
Time Frame
change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Kosch, MS
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

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Beef Burger Versus a Vegetarian Burger

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