NCT06433115招募中不适用
Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Gut microbial alpha-diversity
研究概览
简要总结
This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.
详细描述
The study is a 6-wk randomized, controlled, and parallel arm clinical trial. Participants will be randomized to consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Outcomes assessed will include metabolic, inflammatory, and gut microbiome markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single Blind
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-45 years of age
- •BMI: 18-35 kg/m2
- •Willingness to consume study foods.
- •Willing to comply with study protocol.
- •Consistent diet and activity patterns for 4 weeks
- •Weight stable (≤5 kg change over the last 3 months)
- •Non-smoker >1 year or more
排除标准
- •Allergies to foods provided in the study
- •Gastrointestinal disease and/or bariatric surgery
- •Uncontrolled hypertension and blood pressure ≥ 180/110
- •Illicit drug use
- •Recent consumption of antibiotics or probiotics
- •Recent start of medications that affect metabolism or appetite.
- •Recent blood donation
- •Drug therapy for coronary artery disease, peripheral artery disease, congestive - heart failure, or dyslipidemia
- •Pregnant or lactating individuals
- •Taste or smell disorders
- •High consumers of red meat or plant-based meat (≥ 4 times/week)
结局指标
主要结局
Gut microbial alpha-diversity
时间窗: Baseline, week 6
Assessed via16S rRNA sequencing
LDL-C concentrations
时间窗: Baseline, week 6
Lipid profile
Interleukin-6 concentrations
时间窗: Baseline, week 6
Inflammatory marker
次要结局
- HDL-C concentrations(Baseline, week 6)
- Glucose concentrations(Baseline, week 6)
- Thigh circumference(Baseline, week 3, and week 6)
- Physical activity scores(Baseline, week 6)
- LPS-binding protein concentration(Baseline, week 6)
- Body mass(Baseline, week 3, and week 6)
- Fat-free mass(Baseline, week 3, and week 6)
- Total hours of sleep(Baseline, week 6)
- Gene expression levels(Baseline, week 6)
- Hip circumference(Baseline, week 3, and week 6)
- Healthy eating index score(Baseline, week 6)
- Total cholesterol concentrations(Baseline, week 6)
- Triglyceride concentrations(Baseline, week 6)
- Insulin concentrations(Baseline, week 6)
- 24 hour appetite ratings(Baseline, week 6)
- Palatability rating of foods(Baseline, week 3, week 6)
- Gut microbiome abundance(Baseline, week 6)
- Fat mass(Baseline, week 3, and week 6)
- Waist circumference(Baseline, week 3, and week 6)
- Acceptance rating of foods(Baseline, week 3, week 6)
- Taste and flavor intensity ratings of foods(Baseline)
- Inflammatory marker concentrations(Baseline, week 6)
研究者
Jaapna Dhillon
Assistant Professor
University of Missouri-Columbia
研究点 (2)
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