NCT06324370

Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)

Bioequivalence of Virgin Coconut Oil (VCO) Among Healthy Filipino Male Adults: An Exploratory Pharmacokinetic Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Food and Nutrition Research Institute, Philippines · Other Government
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed description

Virgin coconut oil (VCO) will be administered with 240 ml water and standardized food on dosing periods, with a 5-day interval between the single-dose (0.6 ml/kg body weight) and the multiple-dose (1.2 ml/kg body weight divided into three doses daily) study periods. For the single-dose study, blood for PK analysis will be collected at pre-dose (-0.5 and 0 hours), then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. For the multiple-dose study, blood samples will be collected on the last day of dosing before the 2nd dose (at -0.5 and 0 hours), and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 14, and 24 hour/s post-dose. Sample collection will be continued after the last multiple dose at the following time points: 48, 72, 96, 120 and 144 hours. In addition, pre-dose blood samples will be collected daily from Day 8-12 to determine trough plasma concentrations and the approach to steady state. Blood samples will be sent to the Ateneo De Manila University (AdMU) for gas chromatography-mass spectrometry (GC-MS) analysis. Established primary and secondary endpoints for pharmacokinetics and safety and tolerability will be evaluated. This study is necessary to establish human data on the pharmacokinetics of virgin coconut oil (VCO).

Conditions

• Pharmacological Action

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-13
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-03-22
• Last updated: 2025-06-11

Locations

1 site across 1 country: Philippines