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Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)

NCT06324370 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-06-11

No results posted yet for this study

Summary

This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI).

Conditions

  • Pharmacological Action

Interventions

DIETARY_SUPPLEMENT

Virgin Coconut Oil

Virgin Coconut Oil (VCO) will be administered with 240 mL water and standardized food during dosing periods.While the participant is standing up, each dose will be administered orally with at least 240 mL of water and standardized meal after an overnight fast of at least 10 hours on each occasion. The time of dosing will be recorded to the nearest minute in the case report form (CRF). No other liquid or solid food intake is permitted during this time. Fluid intake will be ad libitum 4 hours post-dose. There will be a washout interval of 7 days between the single- and multiple-dose studies. Participants will not be permitted to take any prescribed medication or over-the-counter products (including vitamins and herbal supplements) within 14 days prior to dosing or during the course of the study.

Sponsors & Collaborators

  • Ateneo de Manila University

    collaborator OTHER

  • De La Salle Medical and Health Sciences Institute

    collaborator UNKNOWN

  • Food and Nutrition Research Institute, Philippines

    lead OTHER_GOV

Principal Investigators

  • Carl Vincent D. Cabanilla, Bachelor's · Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324370 on ClinicalTrials.gov