Effects of Different Sources of Beef and Plant-based Meat Alternatives on Postprandial Inflammatory and Metabolic Profiles of Consumers

Utah State University2 个研究点分布在 1 个国家目标入组 36 人开始时间: 2023年2月1日最近更新: 2024年4月30日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Utah State University
入组人数: 36
试验地点: 2
主要终点: Inflammatory cytokine biomarker (IL-6) concentrations in plasma samples

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

BACKGROUND

An increasing number of people is interested in consuming either grass-fed beef or plant-based beef alternatives, such as the Impossible BurgerTM or Beyond MeatTM, believing that these choices are beneficial for consumer health; however, little to no work has been performed to study these beliefs and claims. The purpose of this study is to evaluate effects of plant-based meat, grass-fed beef, and grain-fed beef on postprandial plasma inflammatory and metabolite profiles in middle aged adults (30-60 y old). This work will offer new insight into manipulating the acute, post-meal inflammatory state by consumer food choices. It will also provide more insight how food-derived metabolites impact systemic metabolites in the human body through metabolomics analysis. This study will utilize a randomized cross-over design and every participant will consume each type of meat on three separate occasions separated by a minimum of three days.

STUDY OBJECTIVES

To determine the effects of consuming 9 oz of the Impossible BurgerTM, grass-fed beef, or grain-fed beef on 300 min postprandial plasma inflammatory markers (IL-6, TNF-α, C-reactive protein, and VCAM-1).
To determine effects on plasma metabolites (vitamin and mineral derivatives, polyphenols, amino acids etc.) collected through regular blood sampling during the 300 min postprandial phase (at 60 min, 180 min, and 300 min).
To determine the effects on subjective satiety at 15, 30, 60 min and every hour thereafter following consumption.

DESIGN AND PROCEDURES

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Double (Participant, Outcomes Assessor)

盲法说明

Participants will not know which type of burger they consume.

入排标准

年龄范围: 30 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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