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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before meal
Awards & highlights
Study Summary
This trial will study the effects of eating beef, grass-fed beef, or plant-based meat on inflammation & metabolism in 30-60 year olds. Blood samples will be taken before/after food & analyzed to assess impacts of these foods.
Who is the study for?
This trial is for overweight or obese adults aged 30-60 who have been weight stable in the past 3 months. Participants must not be heavy drinkers, pregnant, lactating, allergic to soy, smokers, or have certain health conditions like diabetes or heart failure. They should not be on medications affecting inflammation and can't have had a recent COVID vaccine.Check my eligibility
What is being tested?
The study compares the effects of consuming a grain-fed beef hamburger, grass-fed beef hamburger, or an Impossible Burger on blood markers of inflammation and metabolism. Each participant will eat each type of burger on separate visits with blood samples taken before and after meals at specific intervals.See study design
What are the potential side effects?
There are no direct side effects from eating the burgers mentioned in the study; however, participants may experience discomfort from frequent blood draws such as bruising at the needle site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in mood scores from baseline after eating.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in mood scores from baseline after eating.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inflammatory cytokine biomarker (C-reactive protein) concentrations in plasma samples
Inflammatory cytokine biomarker (IL-6) concentrations in plasma samples
Inflammatory cytokine biomarker (TNF-alpha) concentrations in plasma samples
+2 moreSecondary outcome measures
Mood Questionnaires
Satiety Questionnaire
Taste Questionnaire
Trial Design
6Treatment groups
Active Control
Group I: Sequence 3: Impossible, Grass-Fed, Grain-FedActive Control3 Interventions
On the first visit, an Impossible BurgerTM (250 grams) will be consumed.
On the second visit, a grass-fed beef burger (250 grams) will be consumed.
On the third visit, a grain-fed beef burger (250 grams) will be consumed.
Group II: Sequence 6: Grass-Fed, Impossible, Grain-FedActive Control3 Interventions
On the first visit, a grass-fed beef burger (250 grams) will be consumed.
On the second visit, an Impossible BurgerTM (250 grams) will be consumed.
On the third visit, a grain-fed beef burger (250 grams) will be consumed.
Group III: Sequence 5: Grain-Fed, Impossible, Grass-FedActive Control3 Interventions
On the first visit, a grain-fed beef burger (250 grams) will be consumed.
On the second visit, an Impossible BurgerTM (250 grams) will be consumed.
On the third visit, a grass-fed beef burger (250 grams) will be consumed.
Group IV: Sequence 4: Impossible, Grain-Fed, Grass-FedActive Control3 Interventions
On the first visit, an Impossible BurgerTM (250 grams) will be consumed.
On the second visit, a grain-fed beef burger (250 grams) will be consumed.
On the third visit, a grass-fed beef burger (250 grams) will be consumed.
Group V: Sequence 1: Grain-Fed, Grass-Fed, ImpossibleActive Control3 Interventions
On the first visit, a grain-fed beef burger (250 grams) will be consumed.
On the second visit, a grass-fed beef burger (250 grams) will be consumed.
On the third visit, an Impossible BurgerTM (250 grams) will be consumed.
Group VI: Sequence 2: Grass-Fed, Grain-Fed, ImpossibleActive Control3 Interventions
On the first visit, a grass-fed beef burger (250 grams) will be consumed.
On the second visit, a grain-fed beef burger (250 grams) will be consumed.
On the third visit, an Impossible BurgerTM (250 grams) will be consumed.
Find a Location
Who is running the clinical trial?
Duke UniversityOTHER
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3,420,446 Total Patients Enrolled
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United States Department of Agriculture (USDA)FED
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Utah State UniversityLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medications that could interfere with the study.I have a history of inflammatory diseases like arthritis or hepatitis.I am between 30 and 60 years old.I am unable to understand and give voluntary consent for treatment.I received a COVID vaccine in the last two weeks.I have been diagnosed with cancer, heart failure, diabetes, or COPD.The study leader thinks I can't safely follow the study plan.I have not taken antibiotics in the last 60 days.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence 3: Impossible, Grass-Fed, Grain-Fed
- Group 2: Sequence 6: Grass-Fed, Impossible, Grain-Fed
- Group 3: Sequence 5: Grain-Fed, Impossible, Grass-Fed
- Group 4: Sequence 4: Impossible, Grain-Fed, Grass-Fed
- Group 5: Sequence 1: Grain-Fed, Grass-Fed, Impossible
- Group 6: Sequence 2: Grass-Fed, Grain-Fed, Impossible
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research protocol open to those 18 years and older?
"The requirement for entry into this trial include being aged between 30 and 60."
Answered by AI
How many participants have been included in this research project?
"Affirmative. Clinicaltrials.gov has information showing that this research is presently accepting candidates. This trial was first announced on February 1st 2023 and had its most recent alteration on September 1st 2023. The study requires 40 participants to be recruited at a single medical site."
Answered by AI
Is there still room for participation in this clinical exploration?
"Affirmative. A quick glance at clinicaltrials.gov reveals that recruitment for this trial is in full swing, with the first post dated February 1st 2023 and a recent edit on September 1st of the same year. 40 participants have to be recruited from one site."
Answered by AI
Is opportunity available for me to partake in this experiment?
"This clinical trial is looking to enroll 40 volunteers between the ages of 30 and 60 that are suffering from inflammation. The prerequisites for participation in this study include: Age ≥30 and ≤60 years;, BMI ≥25 and ≤35 kg/m2;, Weight stable in last 3 months (Loss or gain <4%);, Hemoglobin A1C (HbA1C) ≤6.4%;, Fasting plasma glucose concentration <126 mg/dl; additionally all participants must be proficient with English language conversation."
Answered by AI
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