Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Serum lipopolysaccharide binding protein (LBP)
研究概览
简要总结
Shifting away from diets high in animal products towards more plant predominant diets is recommended by many health organizations to both reduce the negative environmental impacts of animal agriculture and to improve health outcomes. As a result, a number of plant-based meat alternatives such as Beyond Meat have been formulated to promote increased plant consumption. However, evidence is limited on the impact of newer plant-based meat alternatives on common cardiometabolic risk factors. The investigators aim to compare the acute metabolic, gastrointestinal, and inflammatory effects of a plant-based meat alternative (i.e., Beyond Meat) versus a comparable beef product within the context of high-fat, "Western-style" meal (i.e., eggs, meat, refined bread product). The investigators will also examine whether these responses differ based on whether individuals have a normal-weight or have overweight/obesity.
详细描述
The investigators will recruit individuals with a BMI in the normal (18.5-24.9 kg/m2) or overweight/ obesity (>25.0 kg/m2) ranges from the Ball State University campus and surrounding communities. Each participant will complete two meal trials in a randomized crossover design. At each meal trial, a intravenous catheter will be inserted and baseline blood sample collected. Next, participants will consume a high-fat, Western style meal consisting of eggs cooked in butter, a croissant and either 4 oz of 80% ground beef or 4 oz of Beyond Meat ("Cookout Classic" variety). The Beyond Meat and beef products have nearly identical macronutrient profiles, allowing for examination of the unique properties of the two protein sources. Regardless of primary protein source (beef or Beyond Meat), each meal will contain 980 calories (60g fat). Following completion of each meal, blood samples will also be collected 1-, 2-, 3-, and 4-hours. The investigators will measure metabolic markers (i.e., triglycerides, glucose, HDL-C) immediately upon sample collection using the Piccolo Xpress clinical chemistry analyzer. Additional blood will be collected and stored as serum in order to measure indicators of inflammation (e.g., IL-6) and intestinal permeability (e.g., lipopolysaccharide binding protein) using commercially available ELISAs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
While complete blinding is not possible (participants will see/taste the food they eat), the investigators will not tell participants whether they are consuming beef or Beyond Meat.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 50 years.
- •Body mass index > 18.5 kg/m2
- •Not pregnant (females only)
- •Not postmenopausal (females only).
- •Not been diagnosed with cardiovascular disease.
- •Not been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
- •Not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- •Does not regularly take anti-inflammatory drugs (more than 2x week).
- •Does not use glucose-lowering drugs (e.g., metformin)
- •Does not use lipid-lowering drugs (e.g., statins)
- •Does not use tobacco products or any illicit drugs.
- •Does not have a pacemaker.
- •Can consume pea products (Beyond Meat is made from pea protein).
排除标准
- •Not between the ages of 18-50
- •Body mass index < 18.5 kg/m2
- •Pregnant (females only)
- •Postmenopausal status (females only).
- •Been diagnosed with cardiovascular disease.
- •Been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
- •Been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
- •Regularly take anti-inflammatory drugs (more than 2x week).
- •Uses glucose-lowering drugs (e.g., metformin)
- •Uses lipid-lowering drugs (e.g., statins)
- •Uses tobacco products or any illicit drugs.
- •Have a pacemaker.
- •Allergic to pea products (Beyond Meat is made from pea protein).
结局指标
主要结局
Serum lipopolysaccharide binding protein (LBP)
时间窗: Through study completion, up to 1 year.
The investigators will measure serum LBP at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
Serum lipopolysaccharide
时间窗: Through study completion, up to 1 year.
The investigators will measure serum lipopolysaccharide at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
Serum interleukin (IL)-6
时间窗: Through study completion, up to 1 year.
The investigators will measure serum IL-6 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
Serum soluble CD14 (sCD14)
时间窗: Through study completion, up to 1 year.
The investigators will measure serum sCD14 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
Serum tumor necrosis factor (TNF)-alpha
时间窗: Through study completion, up to 1 year.
The investigators will measure serum (TNF)-alpha at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
次要结局
- HDL-C(Through study completion, up to 1 year.)
- Glucose(Through study completion, up to 1 year.)
- Triglycerides(Through study completion, up to 1 year.)