Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Concentration of Nitric oxide (NO)
研究概览
简要总结
It is a 12-week study. The participants will follow three different diets, and during each diet period, and the participants will wear our device, and blood samples will be collected.
详细描述
The investigators will conduct a randomized, controlled crossover intervention study. The investigators will enroll 54 participants, aged >18 years, BMI >25 kg/m2 with metabolic syndrome. During the first phase, all participants will consume their habitual diet for 2 weeks to establish baseline. Then participants will be randomized to either a Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF) for 14 days with 2 weeks washout between the different diets. The wearable system will monitor basal levels and the changes for glucose, cholesterol, TG, and NO through sweat analysis and HR, HRV, and PWV for carotid arterial stiffness during each diet intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •United States Veterans
- •Male or female, age 18-55 years at the time of signing informed consent.
- •at least 2 of the following: waist circumference > 40" for men and 35" for women, FBS >100 mg/dl, triglycerides > 150 but < 500 mg/dL, HDL < 40 mg/dL, Pre- hypertension or hypertension (BP>120/80 mmHg but <150/90 mmHg)
排除标准
- •History of diabetes require medications
- •History of alcohol intake ≥ 20g/day
- •History of cirrhosis
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of <30 mL/min/1.73 m2
- •History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
- •Any unstable medical conditions or terminal diagnosis.
- •Any participant who is unwilling to sign an informed consent form will not be admitted into the study.
研究组 & 干预措施
Diet 1 (one of the three kinds of diets)
participants will be randomized to diet 1 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF) (Dietary Supplement)
Diet 1 (one of the three kinds of diets)
participants will be randomized to diet 1 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: The integrated sweat sensor and vascular sensor (wearable) (Device)
Diet 1 (one of the three kinds of diets)
participants will be randomized to diet 1 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: continuous glucose monitor (CGM) (Device)
Diet 2 (one of the two remaining kinds of diets, excluding Diet 1)
participants will be randomized to diet 2 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF) (Dietary Supplement)
Diet 2 (one of the two remaining kinds of diets, excluding Diet 1)
participants will be randomized to diet 2 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: The integrated sweat sensor and vascular sensor (wearable) (Device)
Diet 2 (one of the two remaining kinds of diets, excluding Diet 1)
participants will be randomized to diet 2 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: continuous glucose monitor (CGM) (Device)
Diet 3 (the final remaining diet)
participants will be randomized to diet 3 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: Mediterranean diet (MED), high-fat/low carb diet (HF/LC), and low-fat diet (LF) (Dietary Supplement)
Diet 3 (the final remaining diet)
participants will be randomized to diet 3 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: The integrated sweat sensor and vascular sensor (wearable) (Device)
Diet 3 (the final remaining diet)
participants will be randomized to diet 3 for 2 weeks. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: continuous glucose monitor (CGM) (Device)
Habitual diet as a baseline
All participants will consume their habitual diet for 2 weeks to establish baseline. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: The integrated sweat sensor and vascular sensor (wearable) (Device)
Habitual diet as a baseline
All participants will consume their habitual diet for 2 weeks to establish baseline. A continuous glucose monitor (CGM) will be placed and the integrated sweat sensor and vascular sensor will be administered.
干预措施: continuous glucose monitor (CGM) (Device)
结局指标
主要结局
Concentration of Nitric oxide (NO)
时间窗: From enrollment to the end of measurement at 12 weeks
The concentration of Nitric oxide (NO) (ppm) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Concentration of glucose
时间窗: From enrollment to the end of measurement at 12 weeks
The concentration of glucose (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism
Concentration of cholesterol
时间窗: From enrollment to the end of measurement at 12 weeks
The concentration of cholesterol (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Concentration of triacylglycerol (TG)
时间窗: From enrollment to the end of measurement at 12 weeks]
The concentration of triacylglycerol (TG) (mg/dL) will be measured during each visit, across the different diets, to evaluate changes in metabolism.
Measurement of heart rate (HR)
时间窗: From enrollment to the end of measurement at 12 weeks
The heart rate (HR) (bpm) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
Measurement of heart rate variability (HRV)
时间窗: From enrollment to the end of measurement at 12 weeks
The heart rate variability (HRV) (ms) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness indirectly.
Measurement of pulse wave velocity (PWV)
时间窗: From enrollment to the end of measurement at 12 weeks
The pulse wave velocity (PWV) (m/s) will be measured during each visit, across the different diets, to evaluate changes in vessel stiffness.
Body weight
时间窗: From enrollment to the end of measurement at 12 weeks
The body weight (BW) (kg) will be measured during each visit, across the different diets, to evaluate changes of BMI.
Height
时间窗: From enrollment to the end of measurement at 12 weeks
The height (m) will be measured during each visit, across the different diets, to evaluate changes in BMI.
次要结局
- BMI(From enrollment to the end of measurement at 12 weeks)