NCT04034160

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

July 19, 2019

Last Update Submit

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

EXPERIMENTAL

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

vegetarian burger consumption group

ACTIVE COMPARATOR

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

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.

burger consumption group

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.

vegetarian burger consumption group

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cindy Kosch, MS

    Loma Linda University

    PRINCIPAL INVESTIGATOR

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

Locations