瘦牛肉消费对心脏代谢健康和肠道微生物组的影响
This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jaapna Dhillon
- 电话号码：573-884-2103
- 邮箱：jdhillon@missouri.edu
学习地点
-
-
Missouri
-
Columbia、Missouri、美国、65211
- 招聘中
- University of Missouri-Columbia
-
首席研究员：
- Jaapna Dhillon, PhD
-
接触：
- Jaapna Dhillon
- 电话号码：573-884-2103
- 邮箱：jdhillon@missouri.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Allergies to foods provided in the study
- Diabetes
- 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lean (≥90%) Grass-Fed Beef
The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks. |
The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. |
|
实验性的：Lean (≥90%) Grain-Fed Beef
The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks. |
The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. |
|
有源比较器：Plant-Based Meat
Plant-based meat (beyond meat product) would be macronutrient matched to the same quantities of meat prescribed for a given energy level. Participants will consume meals for six weeks. |
Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
LDL-C concentrations
大体时间：Baseline, week 6
|
Lipid profile |
Baseline, week 6
|
|
Interleukin-6 concentrations
大体时间：Baseline, week 6
|
Inflammatory marker |
Baseline, week 6
|
|
Gut microbial alpha-diversity
大体时间：Baseline, week 6
|
Assessed via16S rRNA sequencing |
Baseline, week 6
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
HDL-C concentrations
大体时间：Baseline, week 6
|
Lipid profile |
Baseline, week 6
|
|
Total cholesterol concentrations
大体时间：Baseline, week 6
|
Lipid profile |
Baseline, week 6
|
|
Triglyceride concentrations
大体时间：Baseline, week 6
|
Lipid profile |
Baseline, week 6
|
|
Gut microbiome abundance
大体时间：Baseline, week 6
|
16S rRNA sequencing |
Baseline, week 6
|
|
LPS-binding protein concentration
大体时间：Baseline, week 6
|
Intestinal permeability marker |
Baseline, week 6
|
|
Glucose concentrations
大体时间：Baseline, week 6
|
Blood Glucose |
Baseline, week 6
|
|
Insulin concentrations
大体时间：Baseline, week 6
|
Insulin |
Baseline, week 6
|
|
Body mass
大体时间：Baseline, week 3, and week 6
|
Measured in kg |
Baseline, week 3, and week 6
|
|
Fat mass
大体时间：Baseline, week 3, and week 6
|
Fat mass |
Baseline, week 3, and week 6
|
|
Fat-free mass
大体时间：Baseline, week 3, and week 6
|
Fat-free mass |
Baseline, week 3, and week 6
|
|
Waist circumference
大体时间：Baseline, week 3, and week 6
|
Waist circumference |
Baseline, week 3, and week 6
|
|
Hip circumference
大体时间：Baseline, week 3, and week 6
|
Hip Circumference |
Baseline, week 3, and week 6
|
|
Thigh circumference
大体时间：Baseline, week 3, and week 6
|
Thigh Circumference |
Baseline, week 3, and week 6
|
|
24 hour appetite ratings
大体时间：Baseline, week 6
|
24-hour appetite ratings assessed on VAS |
Baseline, week 6
|
|
Physical activity scores
大体时间：Baseline, week 6
|
Activity assessment using Actigraphs |
Baseline, week 6
|
|
Total hours of sleep
大体时间：Baseline, week 6
|
Sleep diary |
Baseline, week 6
|
|
Palatability rating of foods
大体时间：Baseline, week 3, week 6
|
Hedonic general labelled magnitude scale (gLMS) |
Baseline, week 3, week 6
|
|
Acceptance rating of foods
大体时间：Baseline, week 3, week 6
|
9-point food action rating scale |
Baseline, week 3, week 6
|
|
Taste and flavor intensity ratings of foods
大体时间：Baseline
|
Sensory intensity scales |
Baseline
|
|
Gene expression levels
大体时间：Baseline, week 6
|
Transcriptomics analyses |
Baseline, week 6
|
|
Inflammatory marker concentrations
大体时间：Baseline, week 6
|
Inflammatory markers |
Baseline, week 6
|
|
Healthy eating index score
大体时间：Baseline, week 6
|
NCI diet history questionnaire |
Baseline, week 6
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Metabolite intensities
大体时间：Baseline, week 6
|
Untargeted and targeted metabolomics |
Baseline, week 6
|
|
Nutrient intakes
大体时间：Baseline, week 3, week 6
|
24 hours dietary recall |
Baseline, week 3, week 6
|
合作者和调查者
调查人员
- 首席研究员：Jaapna Dhillon, PhD、University of Missouri-Columbia
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2097458
- 2097458 (其他标识符：University of Missouri)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
IPD 共享时间框架
Immediately following publication. No end date.
IPD 共享访问标准
Data will be deposited in online repositories
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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