Centella Asiatica in Older Adults
- Conditions
- Endothelial Dysfunction
- Interventions
- Dietary Supplement: Centella AsiaticaDietary Supplement: Placebo Comparator
- Registration Number
- NCT06472791
- Lead Sponsor
- National University of Natural Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
● 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Centlla Asiatica Centella 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. Placebo Placebo Comparator Matched number of capsules per week. Capsules will contain microcrystalline cellulose.
- Primary Outcome Measures
Name Time Method Endothelial Function 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.
- Secondary Outcome Measures
Name Time Method Blood Pressure Week 4 Blood pressure will be measured at each visit with an automatic sphygmomanometer.
Heart Rate Variability (HRV) Week 4 HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.
Body Mass Index (BMI) Week 4 BMI will be calculated each visit by measuring the participant's height and weight.
Trial Locations
- Locations (1)
Helfgott Research Institute
🇺🇸Portland, Oregon, United States