Effects of L-Citrulline Supplementation on Vascular Function During Fasted and Acute Hyperglycemia in Middle-aged and Older Women With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Macrovascular Endothelial function in the fasted condition
研究概览
简要总结
The objective of this project is to provide evidence that L-Citrulline (CIT) supplementation can improve vascular function in the fasted and acute hyperglycemia conditions in middle-aged and older women with metabolic syndrome.
详细描述
Using a double-blind, randomized, placebo-controlled, and parallel design, middle-aged and older women with metabolic syndrome will be randomized into receiving either CIT supplementation (10g/day) or placebo (Microcrystalline Cellulose) for 4 weeks.
The first visit will be approximately 1hr and 30 minutes. The 2nd and 3rd visits will each be approximately 2hrs and 30 minutes, separated by 4 weeks in between each visit. During visits 2 and 3, vascular measurements will be assessed in the fasted state and 30, 60, and 90 minutes after acute glucose ingestion (75g).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must present at least 3 of the following 5 cardiometabolic risk factors
- •Waist circumference ≥88 cm
- •Fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%.
- •Blood pressure ≥130 mm Hg
- •Triglyceride ≥ 150 mg/dL
- •HDL <50 mg/dL
- •The following are also inclusion criteria's:
- •Women aged 45-79 years old
- •Body mass index ≤ 39.9 kg/m2
- •Sedentary (defined as < 120 min/week of exercise)
- •Abstain from any dietary supplements with vascular effects for one month prior to the beginning of the study and until participation in study has terminated.
排除标准
- •< 45 and > 79 years of age
- •Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, biguanides, insulin, beta blockers, statins, verapamil)
- •Systolic blood pressure ≥ 160 mmHg
- •BMI > 40 kg/m2
- •Recent changes in medication (3 months)
- •Current smoking any tobacco use
- •Cardiovascular disease, diabetes (Type 1 or 2), and other metabolic or chronic diseases
- •More than 7 alcoholic drinks/week of consumption
研究组 & 干预措施
L-citrulline
L-citrulline: 10 grams/day
干预措施: L-Citrulline supplementation (Dietary Supplement)
Placebo
Microcrystalline Cellulose
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Macrovascular Endothelial function in the fasted condition
时间窗: 4 weeks
Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at baseline and after 4 weeks of supplementation.
Microvascular digital endothelial function in the fasted condition
时间窗: 4 weeks
Endothelial function will be measured using peripheral (finger) arterial tonometry (EndoPAT device) during reactive hyperemia at baseline and after 4 weeks of supplementation.
Central and peripheral arterial stiffness in the fasted condition
时间窗: 4 weeks
Arterial stiffness will be measured using central (carotid-femoral) and peripheral (femoral-ankle) PWV at baseline and after 4 weeks of supplementation.
Macrovascular Endothelial function during acute hyperglycemia
时间窗: 4 weeks
Endothelial function will be measured via brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Microvascular forearm endothelial function during acute hyperglycemia
时间窗: 4 weeks
Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Blood pressure in the fasted condition
时间窗: 4 weeks
Brachial and aortic blood pressures will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured at baseline and after 4 weeks of supplementation.
Stroke volume in the fasted condition
时间窗: 4 weeks
Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation.
Central arterial stiffness during acute hyperglycemia
时间窗: 4 weeks
Arterial stiffness will be measured using central (carotid-femoral) PWV at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Blood pressure during acute hyperglycemia
时间窗: 4 weeks
Brachial and aortic blood pressures (systolic and diastolic) will be assessed using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Fineometer). Blood pressure will be measured after an oral glucose ingestion at 30, 60, and 90 minutes at baseline and after 4 weeks of supplementation.
Microvascular endothelial function in the fasted condition
时间窗: 4 weeks
Endothelial function will be measured using forearm muscle oxygenation (near-infrared spectroscopy) will assessed during reactive hyperemia at baseline and after 4 weeks of supplementation.
Total peripheral resistance in the fasted condition.
时间窗: 4 weeks
Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at baseline and after 4 weeks of supplementation.
Total peripheral resistance during acute hyperglycemia
时间窗: 4 weeks
Total peripheral resistance will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
Stroke volume during acute hyperglycemia
时间窗: 4 weeks
Stroke volume will be measured using an automated photoplethysmography finger cuff (Finometer) at 30, 60, and 90 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation.
24-hour ambulatory blood pressure monitoring
时间窗: 4 weeks
An ambulatory blood pressure cuff, measuring blood pressure for 24-hours will be obtained on two separate days at baseline and after 4 weeks of supplementation.
次要结局
- Serum Nitric Oxide levels(4 weeks)
- Serum Endothelin-1 levels(4 weeks)
- Serum arginine levels(4 weeks)
- Serum arginase levels(4 weeks)
- Serum glucose and insulin levels.(4 weeks)
研究者
Arturo Figueroa
Arturo Figueroa, Principal Investigator
Texas Tech University