Clinical trial NCT06472791: Centella Asiatica in Older Adults
Official title: Effect of Centella Asiatica on Vascular Endothelial Function in Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to take either a placebo or a Centella Asiatica-containing dietary supplement for four weeks
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

● 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Endothelial Function
timeFrame: Baseline
measure: Endothelial Function
timeFrame: Day 1
measure: Endothelial Function
timeFrame: Week 4
Secondary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: Baseline
measure: Heart Rate Variability (HRV)
timeFrame: Day 1
measure: Heart Rate Variability (HRV)
timeFrame: Week 4
measure: Blood Pressure
timeFrame: Baseline
measure: Blood Pressure
timeFrame: Day 1
measure: Blood Pressure
timeFrame: Week 4
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Day 1
measure: Body Mass Index (BMI)
timeFrame: Week 4
Other outcomes:
measure: Adherence
timeFrame: Week 4
measure: Adherence
timeFrame: Week 4
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: Week 4
measure: Urea Nitrogen
timeFrame: Baseline
measure: Urea Nitrogen
timeFrame: Week 4
measure: Creatinine
timeFrame: Baseline
measure: Creatinine
timeFrame: Week 4
measure: Urea Nitrogen to creatinine ratio
timeFrame: baseline
measure: Urea Nitrogen to creatinine ratio
timeFrame: Week 4
measure: Sodium
timeFrame: Baseline
measure: Sodium
timeFrame: Week 4
measure: Potassium
timeFrame: Baseline
measure: Potassium
timeFrame: Week 4
measure: Chloride
timeFrame: Baseline
measure: Chloride
timeFrame: Week 4
measure: Carbon Dioxide
timeFrame: baseline
measure: Carbon Dioxide
timeFrame: week 4
measure: Calcium
timeFrame: Baseline
measure: Calcium
timeFrame: Week 4
measure: Total Protein
timeFrame: Baseline
measure: Total Protein
timeFrame: Week 4
measure: Albumin
timeFrame: Baseline
measure: Albumin
timeFrame: Week 4
measure: Globulin
timeFrame: baseline
measure: Globulin
timeFrame: Week 4
measure: Albumin to Globulin ratio
timeFrame: Baseline
measure: Albumin to Globulin ratio
timeFrame: Week 4
measure: Bilirubin
timeFrame: baseline
measure: Bilirubin
timeFrame: Week 4
measure: Alkaline Phosphatase
timeFrame: baseline
measure: Alkaline Phosphatase
timeFrame: Week 4
measure: aspartate aminotransferase
timeFrame: Baseline
measure: aspartate aminotransferase
timeFrame: Week 4
measure: Alanine aminotransferase
timeFrame: baseline
measure: Alanine aminotransferase
timeFrame: Week 4
measure: Estimated glomerular filtration rate
timeFrame: baseline
measure: Estimated glomerular filtration rate
timeFrame: Week 4
Locations:
city: Portland
country: United States
facility: Helfgott Research Institute
state: Oregon
Study officials:
References: