Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO)

NCT06324370 | Active Not Recruiting DMC

• 1 other identifier: FIERC-2022-023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacokinetic Study; Bioequivalence; Virgin Coconut Oil; Filipino; Philippines

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (AUC0-t)

  Area under the concentration-time curve from administration to the last observed concentration at time t hr

  25 days

• Pharmacokinetics (Cmax)

  Maximum plasma concentration

  25 days

Secondary Outcomes (24)

• Pharmacokinetics (AUC0-inf)

  25 days

• Pharmacokinetics (tmax)

  25 days

• Pharmacokinetics (Kel)

  25 days

• Pharmacokinetics (t1/2)

  25 days

• Vital Signs (Systolic and Diastolic Blood Pressure)

  25 days

Study Arms (1)

Healthy Filipino male participants (18 to 45 yrs old)

EXPERIMENTAL

Healthy Filipino male participants 18 to 45 years old with optimum weight as related to height and body frame. 1.2ml/kg/dose of virgin coconut oil (VCO) will be administered orally with 240 ml of water and standardized food for a single dose, and 0.6ml/kg/dose of virgin coconut oil (VCO) with 240 ml of water and standardized food twice a day for 7 days for multiple doses.

Dietary Supplement: Virgin Coconut Oil

Interventions

Virgin Coconut Oil DIETARY_SUPPLEMENT

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.

Also known as: VCO

Healthy Filipino male participants (18 to 45 yrs old)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Filipino male
• years of age
• signed written informed consent obtained
• body-mass index of ≥18.5 kilogram per meter-squared (kg/m2) and ≤ 24.9 kg/m2, with body weight not less than 50 kilogram(kg)

You may not qualify if:

• history of allergy and/or sensitivity to virgin coconut oil, any of its constituents, or related drugs
• positive Coronavirus Disease (COVID-19) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test
• history of anaphylaxis or angioedema
• systolic Blood Pressure (BP) of less than 90 mm Hg and/or diastolic BP of less than 60 mm Hg
• pulse rate of less than 50 beats/minute
• body weight +/-15% optimum weight as related to height and body frame
• history of tuberculosis or use of anti-tuberculosis drugs within 6 months prior to entry into study clinically significant gastrointestinal, cardiovascular, renal, hepatic, endocrine, metabolic, neurologic, psychiatric, hematological or other abnormalities, as judged by the Investigator
• history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes
• gastrointestinal disorders which may impair drug absorption, or other conditions which could modify the absorption of the study drug, as judged by the Investigator clinically significant deviation in the clinical chemistries (liver and renal function tests) and hematology at visit 1 which may impair assessment, as judged by the Investigator
• positive pre-study urine drug screen
• positive/reactive Hepatitis B and human immunodeficiency virus (HIV)
• use of any prescription drug within 30 days or any over-the-counter (OTC) drug within 14 days prior to and during the study inaccessibility of veins in left and right arm donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
• subjects who cannot abstain from grapefruit, citrus fruits and food and/or beverages that contain caffeine or other xanthines
• an unusual diet, for whatever reason, e.g., low sodium diet, for two weeks prior to receiving any medication and throughout subject's participation in the study current smoker or smoking within two months prior to study enrollment
• consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study (one drink is equal to one unit of alcohol - one glass wine, half pint beer, and one measure/one ounce of spirit)

Sponsors & Collaborators

• Food and Nutrition Research Institute, Philippines: lead
• Ateneo de Manila University: collaborator
• De La Salle Medical and Health Sciences Institute: collaborator

Study Sites (1)

Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)

City of Taguig, National Capital Region, 1630, Philippines

Location

Study Officials

• Carl Vincent D. Cabanilla, Bachelor's

  Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This will be an open-label pharmacokinetic study in healthy Filipino male human participants under fed conditions.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Science Research Specialist

Model Details: This will be a two-sequence (single- and multiple-dose) pharmacokinetic study in healthy Filipino male human participants under fed conditions.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: March 22, 2024
• Study Start: April 13, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)