Milk Consumption On Cardiovascular Risk Factors In Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Total Cholesterol
研究概览
简要总结
The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of 3 of the following risk factors:
- •fasting plasma glucose ≥100 mg/dL (or medical therapy for elevated glucose)
- •HDL-C <40 mg/dL in men or <50 mg/dL in women (or medical therapy for reduced HDL-C)
- •Triglycerides ≥150 mg/dL (or medical therapy for elevated triglycerides)
- •Waist circumference >102 cm for men and >88 cm for women
- •Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg (or medical therapy for hypertension)
排除标准
- •Cardiovascular disease diagnosis
- •Type 1 or 2 diabetes diagnosis
- •Dairy allergy or lactose intolerance
- •Self-reported high baseline dairy intake (>3 servings per day)
- •>3 hours of physical activity per week
- •Pregnant women
- •Inflammatory bowel disease
- •Chronic steroid use
- •Allergy to metal
- •GLP-1 agonist use
- •Patients on medications related to metabolic syndrome where dose adjustments are planned to be made during the study period.
研究组 & 干预措施
Full-fat diet first then Low-fat diet
干预措施: Full-fat diet (Other)
Full-fat diet first then Low-fat diet
干预措施: Low-fat diet (Other)
Low-fat diet first then Full-fat diet
干预措施: Full-fat diet (Other)
Low-fat diet first then Full-fat diet
干预措施: Low-fat diet (Other)
结局指标
主要结局
Change in Total Cholesterol
时间窗: Baseline, Week 3, Week 5, Week 8
Total Cholesterol will be measured by a blood sample and reported as mg/dL
Change in HDL-C (High Density Lipoprotein Cholesterol)
时间窗: Baseline, Week 3, Week 5, Week 8
High Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Change in LDL-C (Low Density Lipoprotein Cholesterol)
时间窗: Baseline, Week 3, Week 5, Week 8
Low Density Lipoprotein Cholesterol will be measured by a blood sample and reported as mg/dL
Change in Triglycerides
时间窗: Baseline, Week 3, Week 5, Week 8
Triglycerides will be measured by a blood sample and reported as mg/dL
Change in Blood Glucose
时间窗: Baseline, Week 3, Week 5, Week 8
Blood Glucose will be measured by a blood sample and reported as mg/dL
Change in Hemoglobin A1c
时间窗: Baseline, Week 3, Week 5, Week 8
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin.
Change in C-reactive protein
时间窗: Baseline, Week 3, Week 5, Week 8
C-reactive protein will be measured by a blood sample and reported as mg/L
Change in Lipoprotein
时间窗: Baseline, Week 3, Week 5, Week 8
Lipoprotein will be measured by a blood sample and reported as mg/dL
Change in Macrovascular Function
时间窗: Baseline, Week 3, Week 5, Week 8
Peripheral macrovascular function is the maximal percent change in brachial artery following cuff release and will be assessed via flow-mediated dilation and reported as a percentage
Change in Microvascular Function
时间窗: Baseline, Week 3, Week 5, Week 8
Quantification of the area under the curve of the brachial artery blood flow following cuff release
次要结局
未报告次要终点
研究者
Joshua R. Smith
Principal Investigator
Mayo Clinic