Beef and Plant Burger Metabolomics Study

NCT05690061 | Active Not Recruiting

• 1 other identifier: 12499
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of meat on inflammatory and metabolite profiles in middle-aged individuals after an acute meal. Up to 36 adults, who are overweight or obese and between 30-60 years old will undergo a consent/screening visit, followed by three study visits. On separate visits to the clinical research facilities at the Center for Human Nutrition Studies, participants will consume either 9 oz (250 grams) of cooked grain-fed beef, grass-fed beef, or a plant-based meat alternative (Impossible Burger). Blood will be drawn prior to food consumption and three more times after eating the meal at 1h, 3h, and 5h after participants finishing their meal. The investigators will use those blood samples to determine the impacts of these foods on inflammatory markers and metabolite profiles (compounds that circulate in our blood such as amino acids, fatty acids, and phenolics).

Conditions

Inflammatory Response

Keywords

Metabolomics; Human Nutrition; Meat; Plant-based Meat Alternative

Outcome Measures

Primary Outcomes (5)

• Inflammatory cytokine biomarker (IL-6) concentrations in plasma samples

  Inflammatory biomarker concentrations of IL-6 (pg/ml) will be measured using ELISA kits at the Center for Human Nutrition Studies at Utah State University. Blood samples will be obtained via phlebotomy before the consumption of the meal, and at time points 60 minutes, 180 minutes, and 300 minutes after consumption of the meal, centrifuged immediately and stored at -80ºC until analyses are performed.

  Change from fasting concentrations after eating.

• Inflammatory cytokine biomarker (C-reactive protein) concentrations in plasma samples

  Inflammatory biomarker concentrations of C-reactive protein (CRP; ng/ml) will be measured using ELISA kits at the Center for Human Nutrition Studies at Utah State University. Blood samples will be obtained before the consumption of the meal, and at time points 60 minutes, 180 minutes, and 300 minutes after consumption of the meal, centrifuged immediately, and stored at -80ºC until analyses are performed.

  Change from fasting concentrations after eating.

• Inflammatory cytokine biomarker (TNF-alpha) concentrations in plasma samples

  Inflammatory biomarker concentrations of TNF-alpha (pg/ml) will be measured using ELISA kits at the Center for Human Nutrition Studies at Utah State University. Blood samples will be obtained before the consumption of the meal, and at time points 60 minutes, 180 minutes, and 300 minutes after consumption of the meal, centrifuged immediately, and stored at -80ºC until analyses are performed.

  Change from fasting concentrations after eating.

• Inflammatory cytokine biomarker (Vascular Adhesion Molecule-1) concentrations in plasma samples

  Inflammatory biomarker concentrations of Vascular Adhesion Molecule-1 (ng/ml) will be measured using ELISA kits at the Center for Human Nutrition Studies at Utah State University. Blood samples will be obtained before the consumption of the meal, and at time points 60 minutes, 180 minutes, and 300 minutes after consumption of the meal, centrifuged immediately, and stored at -80ºC until analyses are performed.

  Change from fasting concentrations after eating.

• Relative abundance of metabolites in plasma samples using triple quad LC/MS-MS

  Relative abundance (arbitrary units) of plasma metabolites after each meal will be measured using high-performance liquid chromatography tandem mass-spectrometry (LC/MS-MS). This analysis allows the simultaneous high-resolution measurement of a broad range of metabolites and will give insight into how food-derived metabolites from different meals impact metabolic pathways of human health. Blood samples will be obtained before each meal, and three times after the meal is consumed at time 60 minutes, 180 minutes, and 300 minutes, and centrifuged immediately and stored at -80ºC until analyses are performed. Multivariate statistical analysis and Partial least squares Discriminant Analysis will be used to identify features changed over time for each meal.

  Change from fasting concentrations after eating.

Secondary Outcomes (3)

• Satiety Questionnaire

  Immediately before meal

• Taste Questionnaire

  Immediately after eating

• Mood Questionnaires

  Change in mood scores from baseline after eating.

Study Arms (6)

Sequence 1: Grain-Fed, Grass-Fed, Impossible

ACTIVE COMPARATOR

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.

Dietary Supplement: Grain-Fed Beef Hamburger; Dietary Supplement: Grass-Fed Beef Hamburger; Dietary Supplement: Impossible BurgerTM

Sequence 2: Grass-Fed, Grain-Fed, Impossible

ACTIVE COMPARATOR

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.

Dietary Supplement: Grain-Fed Beef Hamburger; Dietary Supplement: Grass-Fed Beef Hamburger; Dietary Supplement: Impossible BurgerTM

Sequence 3: Impossible, Grass-Fed, Grain-Fed

ACTIVE COMPARATOR

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.

Dietary Supplement: Grain-Fed Beef Hamburger; Dietary Supplement: Grass-Fed Beef Hamburger; Dietary Supplement: Impossible BurgerTM

Sequence 4: Impossible, Grain-Fed, Grass-Fed

ACTIVE COMPARATOR

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.

Dietary Supplement: Grain-Fed Beef Hamburger; Dietary Supplement: Grass-Fed Beef Hamburger; Dietary Supplement: Impossible BurgerTM

Sequence 5: Grain-Fed, Impossible, Grass-Fed

ACTIVE COMPARATOR

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.

Dietary Supplement: Grain-Fed Beef Hamburger; Dietary Supplement: Grass-Fed Beef Hamburger; Dietary Supplement: Impossible BurgerTM

Sequence 6: Grass-Fed, Impossible, Grain-Fed

ACTIVE COMPARATOR

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.

Dietary Supplement: Grain-Fed Beef Hamburger; Dietary Supplement: Grass-Fed Beef Hamburger; Dietary Supplement: Impossible BurgerTM

Interventions

Grain-Fed Beef Hamburger DIETARY_SUPPLEMENT

Bowl of grain-fed beef hamburger cooked without seasonings. 250 grams of uncooked hamburger weighed out, then cooked in a non-stick pan for 8 minutes, no seasoning or oils were used and rendered fat was poured into serving bowl.

Sequence 1: Grain-Fed, Grass-Fed, Impossible; Sequence 2: Grass-Fed, Grain-Fed, Impossible; Sequence 3: Impossible, Grass-Fed, Grain-Fed; Sequence 4: Impossible, Grain-Fed, Grass-Fed; Sequence 5: Grain-Fed, Impossible, Grass-Fed; Sequence 6: Grass-Fed, Impossible, Grain-Fed

Grass-Fed Beef Hamburger DIETARY_SUPPLEMENT

Bowl of grass-fed, grass-finished beef hamburger cooked without seasonings. 250 grams of uncooked hamburger weighed out, then cooked in a non-stick pan for 8 minutes, no seasoning or oils were used and rendered fat was poured into serving bowl.

Sequence 1: Grain-Fed, Grass-Fed, Impossible; Sequence 2: Grass-Fed, Grain-Fed, Impossible; Sequence 3: Impossible, Grass-Fed, Grain-Fed; Sequence 4: Impossible, Grain-Fed, Grass-Fed; Sequence 5: Grain-Fed, Impossible, Grass-Fed; Sequence 6: Grass-Fed, Impossible, Grain-Fed

Impossible BurgerTM DIETARY_SUPPLEMENT

Bowl of plant-based Impossible burger cooked without seasonings. 250 grams of uncooked Impossible burger weighed out, then cooked in a non-stick pan for 8 minutes, no seasoning or oils were used and rendered fat was poured into serving bowl.

Sequence 1: Grain-Fed, Grass-Fed, Impossible; Sequence 2: Grass-Fed, Grain-Fed, Impossible; Sequence 3: Impossible, Grass-Fed, Grain-Fed; Sequence 4: Impossible, Grain-Fed, Grass-Fed; Sequence 5: Grain-Fed, Impossible, Grass-Fed; Sequence 6: Grass-Fed, Impossible, Grain-Fed

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Subjects must be able to speak and understand English to participate in this study

You may not qualify if:

• Use of medications that are known to affect the study outcome measures (e.g., NSAIDs, corticosteroids) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for this study;
• Consuming \>14 drinks per week;
• Use of cigarettes (or other tobacco products) in last 3 months;
• COVID vaccine within the last two weeks;
• Engaged in high-level competitive exercise (e.g., triathlon, marathon, powerlifting);
• Any inflammatory diseases(e.g. autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis);
• Diagnoses of active malignancy, congestive heart failure, diabetes mellitus and/or chronic obstructive pulmonary disease;
• Use of antibiotics in last 60 days;
• Pregnant (or planning to in the next month) or lactating women;
• Soy allergy;
• Subjects who the study PI considers unable to safely complete the study protocol;
• Persons who are not able to grant voluntary informed consent;
• Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits;
• Vegetarian

Sponsors & Collaborators

• Utah State University: lead
• Duke University: collaborator
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Center for Human Nutrition Studies

Logan, Utah, 84322, United States

Location

Related Publications (1)

• Cloward J, Mason O, DeJesus I, Broadbent J, Payne T, Wengreen HJ, van Vliet S. Comparing Postprandial Inflammatory Responses to a Plant-Based Meat Alternative, Grass-Finished Beef, and Grain-Finished Beef in Healthy Middle-Aged Adults: A Three-Group Randomized Crossover Trial. Am J Clin Nutr. 2026 Jan 8:101192. doi: 10.1016/j.ajcnut.2026.101192. Online ahead of print.

  PMID: 41519303 DERIVED

Related Links

• Center for Human Nutrition Studies

Study Officials

• Stephan van Vliet, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which type of burger they consume.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized cross-over design with 250 g of cooked meat (grain-fed hamburger, grass-fed hamburger, Impossible Burger) ingested and blood draws, urine, and questionnaires collected on separate visits.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 19, 2023
• Study Start: February 1, 2023
• Primary Completion: December 23, 2023
• Study Completion: December 16, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Study protocol is available immediately. The analytical data will be available upon publication.
• Access Criteria: Freely available.

Locations

US (1)