Effect of Centella Asiatica on Vascular Endothelial Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Endothelial Function
研究概览
简要总结
The purpose of this study is to determine the effects of a dietary supplement containing centella asiatica on on vascular endothelial function in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •● Age 50 through 85, male or female
- •Sufficient proficiency in English to understand study purpose and directions
- •Willing and able to give informed consent
- •Able to follow protocol and attend visits
排除标准
- •History of myocardial infarction, known coronary or carotid disease, or heart failure
- •History of stroke, Parkinson's disease, dementia, or other major CNS disorders
- •History of hepatic disease (e.g. hepatitis, cirrhosis)
- •Recent/recurring history of severe life-threatening medical conditions (e.g. cancer, except non-melanoma skin cancers)
- •Active major infectious disease (e.g. pneumonia)
- •Heavy alcohol use (15 drinks or more per week for men or 8 drinks or more per week for women) or substance use disorder
- •Current use of any medication typically used to treat hypertension or lower blood pressure (e.g. beta-blockers, ACE inhibitors)
- •Current use of any medication typically used to prevent the coagulation of blood (e.g. warfarin (Coumadin))
- •Chronic NSAID use (>3 times a week for more than 3 months)
- •Current use of any medication or supplement typically used as a sedative (e.g. zolpidem (Ambien), benzodiazepines (Valium, Xanax), valerian root)
- •Dietary supplements for improving nitric-oxide synthesis (e.g. L-arginine, L-citrulline)
- •Current use of any medication typically used to control hypoglycemia (e.g. biguanides (Metformin))
- •Current use of any medication typically used for erectile dysfunction (e.g. sildenafil (Viagra), tadalafil (Cialis))
- •Pregnant, nursing, or planning a pregnancy within the next 6 weeks
- •Open skin rashes and sores that may interfere with the placement of sensors
研究组 & 干预措施
Placebo
Matched number of capsules per week. Capsules will contain microcrystalline cellulose.
干预措施: Placebo Comparator (Dietary Supplement)
Centlla Asiatica
250 mg/day (1 capsules) for week 1. 500 mg/day (2 capsules) for week 2. 750 mg/day (3 capsules) for week 3. 1000 mg/ day (4 capsules) for week 4.
干预措施: Centella Asiatica (Dietary Supplement)
结局指标
主要结局
Endothelial Function
时间窗: Week 4
Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.
次要结局
- Body Mass Index (BMI)(Week 4)
- Blood Pressure(Week 4)
- Heart Rate Variability (HRV)(Week 4)
研究者
Benjamin Zimmerman
Post-Doctoral Research Investigator
National University of Natural Medicine