Viewing Study NCT04290312



Ignite Creation Date: 2024-05-06 @ 2:22 PM
Last Modification Date: 2024-10-26 @ 1:29 PM
Study NCT ID: NCT04290312
Status: COMPLETED
Last Update Posted: 2020-02-28
First Post: 2020-02-24

Brief Title: Absorption and Bioavailability of Major Monoterpenes in Mastiha Oil a Kinetic Study in Humans
Sponsor: Harokopio University
Organization: Harokopio University

Study Overview

Official Title: Absorption and Bioavailability of Major Monoterpenes in Mastiha Oil a Kinetic Study in Humans
Status: COMPLETED
Status Verified Date: 2020-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Plant derived foods contain large quantities of non-nutrient phytochemicals that have been extensively studied for their beneficial health effects on the prevention of chronic diseases Although research on their health effects is abundant our knowledge on absorption and bioavailability is yet narrow and in some cases zero The concept of bioavailability involves the identification of the fraction of administered compounds that can reach plasma and body tissues in an unchanged form The bioactivity of components in foods that are part of our nutrition either as parent foods or as food supplements is directly related to bioavailability the latter being a necessary step to prove efficacy

Mastiha Oil MO is extracted from the resin of Pistacia Lentiscus var Chia of the Anacardiaceae family a concentrated source of monoterpenes eg α-pinene β-pinene β-myrcene and triterpenes eg mastihadienonic acid isomastihadienonic acid and to a lesser extent of plant sterols simple phenols and approximately 10 MO Assimopoulou Papageorgiou 2005 Paraschos et al 2007 Kaliora Mylona Chiou Petsios Andrikopoulos 2004 MO is a 100 natural product used as a food additive and flavoring and it is manufactured according to the legal standards that make it suitable for human consumption Its nutritional analysis is presented in Supplementary Table 1 A total of 90 components have been detected in MO 50 monoterpene hydrocarbons 20 oxygenated monoterpenes 25 sesquiterpenes Monoterpenes seem to exhibit beneficial health effects contributing to mechanisms of inflammation and oxidative stress Subramaniyan 2017 Madhuri Naik 2017

Research upon the bioavailability of monoterpenes in humans is limited Herein we aimed at investigating the bioavailability of the main monoterpenes of MO in humans for the first time To this end a novel GC-MS-MS method was employed since the tandem MS technique can help overcome matrix difficulties Additionally based on the existing data regarding the antioxidant activity of monoterpenes the effect on human antioxidant capacity was evaluated applying the serum oxidisabilty assay

Detailed Description: After enrolment the volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count On the day of the experiment and after overnight fasting the volunteers will consume g of mastiha oil 1ml and blood samples will be obtained on timepoints 05h 1h 2h 4h 6h and 24h after intake Until timepoint 6h they will be allowed to consume only water After collection the monoterpenes will be identified in plasma samples applying a GC-MS-MS technique Additionally oxidative stress will be evaluated through the CuSO4 technique in serum samples

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None