Centella Asiatica in Older Adults

NCT06472791 | Not Yet Recruiting

• 1 other identifier: BZCA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (3)

• Endothelial Function

  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.

  Baseline

• Endothelial Function

  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.

  Day 1

• Endothelial Function

  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.

  Week 4

Secondary Outcomes (9)

• Heart Rate Variability (HRV)

  Baseline

• Heart Rate Variability (HRV)

  Day 1

• Heart Rate Variability (HRV)

  Week 4

• Blood Pressure

  Baseline

• Blood Pressure

  Day 1

Other Outcomes (38)

• Adherence

  Week 4

• Adherence

  Week 4

• Blood glucose

  Baseline

Study Arms (2)

Centlla Asiatica

EXPERIMENTAL

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.

Dietary Supplement: Centella Asiatica

Placebo

PLACEBO COMPARATOR

Matched number of capsules per week. Capsules will contain microcrystalline cellulose.

Dietary Supplement: Placebo Comparator

Interventions

Centella Asiatica DIETARY_SUPPLEMENT

Centella Asiatica is a perennial, herbaceous plant that is sold as a dietary supplement in the United States under the name Gotu Kola. It has been used for centuries in Ayurvedic and Chinese medicine. Evidence suggests it may help with resilience to aging and cognitive decline. The product for this study will be produced by Arjuna Natural.

Also known as: gotu kola

Centlla Asiatica

Placebo Comparator DIETARY_SUPPLEMENT

The comparator will contain microcystalline cellulose in matched capsules. The comparator product for this study will be produced by Arjuna Natural.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

Helfgott Research Institute

Portland, Oregon, 97201, United States

Location

MeSH Terms

Interventions

Centella asiatica extract

Central Study Contacts

Benjamin Zimmerman, PhD

CONTACT

503-502-1862; bzimmerman@nunm.edu

Anders Gundersen, MS

CONTACT

503-552-1752; agundersen@nunm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Research Investigator

Model Details: Participants will be randomized to take either a placebo or a Centella Asiatica-containing dietary supplement for four weeks

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: December 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)