Centella Asiatica in Older Adults

NCT ID: NCT06472791

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-09-01

Brief Summary

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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

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Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to take either a placebo or a Centella Asiatica-containing dietary supplement for four weeks
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Centella Asiatica

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Centella Asiatica

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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gotu kola

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Natural Medicine

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Zimmerman

Post-Doctoral Research Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helfgott Research Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Central Contacts

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Benjamin Zimmerman, PhD

Role: CONTACT

503-502-1862

Anders Gundersen, MS

Role: CONTACT

503-552-1752

Facility Contacts

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Anders Gundersen, MS

Role: primary

Other Identifiers

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BZCA

Identifier Type: -

Identifier Source: org_study_id

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