Clinical trial NCT04034160: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: serum lipid panel concentration
timeFrame: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Secondary outcomes:
measure: glucose blood concentration
timeFrame: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
measure: hs-CRP blood concentration
timeFrame: change between visit 2(up to 7 days after initial study enrollment) and visit 3(exactly 7 days after Visit 2)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Cindy Kosch, MS
role: PRINCIPAL_INVESTIGATOR
References: