Pharmacokinetic Study of Terpinolene in Healthy Subjects (PKT Study)

NCT06691126 | Completed

• 1 other identifier: 2024-099
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to check if our prediction about the uptake, distribution, and elimination of terpinolene (a food additive commonly found in e.g. fruits and herbs) from the human body is accurate.

Conditions

Pharmacokinetics of Terpinolene

Outcome Measures

Primary Outcomes (1)

• Plasma terpinolene concentration

  Blood samples will be collected at 9 timepoints

  24 hours

Study Arms (1)

Single arm

EXPERIMENTAL

n=15, single oral dose of 200mg of food-grade terpinolene in 5ml of olive oil

Other: Terpinolene in olive oil

Interventions

Terpinolene in olive oil OTHER

Single oral dose of 200mg food-grade terpinolene in 5ml of olive oil

Single arm

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 21-50
• Chinese, Malay and Indian ethnicities
• Male or female
• Adequate fluency in the English language to understand the informed consent process, study instructions and study assessments
• Sufficient vision and hearing to complete the study procedures
• Willing and able to participate and to give written informed consent

You may not qualify if:

• Past (\<3 months prior to the study) or current major metabolic, endocrine, gastrointestinal or cardiovascular disease
• Individuals diagnosed with non-alcoholic fatty liver disease
• Major surgery in the past 2 months
• On chronic medication
• Allergy to olive oil
• Vegetarian/vegan
• Smoking
• Pregnant or lactating
• Alcohol intake \>1 units per day
• Body Mass Index \<18.5 kg/m2 or ≥27 kg/m2
• Body weight \<54 kg
• Member of the study team or their immediate family members

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead
• Institute for Human Development and Potential (IHDP), Singapore: collaborator

Study Sites (1)

Human Development Research Centre, IHDP, A*STAR

Singapore, 117597, Singapore

Location

MeSH Terms

Interventions

terpinolene; Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• James Chan, PhD

  Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Scientist I

Model Details: The study will be carried out as a single arm, unblinded, PK study. The total duration of the study is about 24 hours, excluding screening and enrolment time (up to 1 hour).

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 15, 2024
• Study Start: November 4, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)