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NCT05690061
Beef and Plant Burger Metabolomics Study
Conditions: Inflammatory Response
Sex: All
Ages: 30 Years – 60 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: Utah State University
Location: United States
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 40 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).
Eligibility Criteria
Inclusion Criteria: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 studyExclusion Criteria: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
Source: ClinicalTrials.gov (NCT05690061). StuddyBuddy aggregates publicly available trial information.