Beef Burger Versus a Vegetarian Burger

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034160
• Other study ID #: 5190215
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 28, 2020

Study information

• Verified date: January 2020
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)