Absorption and Bioavailability of Major Monoterpenes in Mastiha Oil; a Kinetic Study in Humans.
NCT ID: NCT04290312
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
9 participants
INTERVENTIONAL
2018-02-01
2020-02-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Mastiha Oil (MO) is extracted from the resin of Pistacia Lentiscus var. Chia (of the Anacardiaceae family), a concentrated source of monoterpenes (e.g., α-pinene, β-pinene, β-myrcene) and triterpenes (e.g., 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mastiha oil
As a control to the experimental design, timepoint 0 was considered.
Mastiha oil
After overnight fasting, the authorized study staff inserted a plastic cannula in an arm vein of the volunteers in order to minimize discomfort during consecutive blood sampling. A blood sample was collected on time point 0h and then the volunteers consumed 1mL of MO. The dose selection was based on the study of Papada et al. (2017) who administered healthy volunteers with 10g of Mastiha (containing \~10% MO). Afterwards blood samples were collected on time points 0.5h, 1h, 2h, 4h, 6h and 24h after MO intake, and were centrifuged at 3000rpm for 10 minutes at 4◦C for plasma and serum isolation. All samples were stored at -80◦C until further analysis.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mastiha oil
After overnight fasting, the authorized study staff inserted a plastic cannula in an arm vein of the volunteers in order to minimize discomfort during consecutive blood sampling. A blood sample was collected on time point 0h and then the volunteers consumed 1mL of MO. The dose selection was based on the study of Papada et al. (2017) who administered healthy volunteers with 10g of Mastiha (containing \~10% MO). Afterwards blood samples were collected on time points 0.5h, 1h, 2h, 4h, 6h and 24h after MO intake, and were centrifuged at 3000rpm for 10 minutes at 4◦C for plasma and serum isolation. All samples were stored at -80◦C until further analysis.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI: 18.5-24.9 kg/m2
Exclusion Criteria
* Alcohol or drug abuse
* Medication, vitamin or inorganic supplements
* Vegan or macrobiotic diet before and during the study
* Gastrointestinal diseases, such as atrophic gastritis, Inflammatory Bowel Disease, peptic ulcer or gastrointestinal cancer
20 Years
40 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Harokopio University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andriana C Kaliora
Assistant Professor in Foods and Human Nutrition
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andriana Kaliora, Ass. Professor
Role: PRINCIPAL_INVESTIGATOR
Harokopio University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Harokopio University
Athens, Attica, Greece
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Papada E, Gioxari A, Brieudes V, Amerikanou C, Halabalaki M, Skaltsounis AL, Smyrnioudis I, Kaliora AC. Bioavailability of Terpenes and Postprandial Effect on Human Antioxidant Potential. An Open-Label Study in Healthy Subjects. Mol Nutr Food Res. 2018 Feb;62(3). doi: 10.1002/mnfr.201700751. Epub 2017 Dec 29.
Abidi A, Aissani N, Sebai H, Serairi R, Kourda N, Ben Khamsa S. Protective Effect of Pistacia lentiscus Oil Against Bleomycin-Induced Lung Fibrosis and Oxidative Stress in Rat. Nutr Cancer. 2017 Apr;69(3):490-497. doi: 10.1080/01635581.2017.1283423. Epub 2017 Feb 17.
J C Furtado NA, Pirson L, Edelberg H, M Miranda L, Loira-Pastoriza C, Preat V, Larondelle Y, Andre CM. Pentacyclic Triterpene Bioavailability: An Overview of In Vitro and In Vivo Studies. Molecules. 2017 Mar 4;22(3):400. doi: 10.3390/molecules22030400.
Garcia-Villalba R, Larrosa M, Possemiers S, Tomas-Barberan FA, Espin JC. Bioavailability of phenolics from an oleuropein-rich olive (Olea europaea) leaf extract and its acute effect on plasma antioxidant status: comparison between pre- and postmenopausal women. Eur J Nutr. 2014 Jun;53(4):1015-27. doi: 10.1007/s00394-013-0604-9. Epub 2013 Oct 26.
Kanellos PT, Kaliora AC, Gioxari A, Christopoulou GO, Kalogeropoulos N, Karathanos VT. Absorption and bioavailability of antioxidant phytochemicals and increase of serum oxidation resistance in healthy subjects following supplementation with raisins. Plant Foods Hum Nutr. 2013 Dec;68(4):411-5. doi: 10.1007/s11130-013-0389-2.
Subramaniyan SD, Natarajan AK. Citral, A Monoterpene Protect Against High Glucose Induced Oxidative Injury in HepG2 Cell In Vitro-An Experimental Study. J Clin Diagn Res. 2017 Aug;11(8):BC10-BC15. doi: 10.7860/JCDR/2017/28470.10377. Epub 2017 Aug 1.
Saidi SA, Ncir M, Chaaben R, Jamoussi K, van Pelt J, Elfeki A. Liver injury following small intestinal ischemia reperfusion in rats is attenuated by Pistacia lentiscus oil: antioxidant and anti-inflammatory effects. Arch Physiol Biochem. 2017 Oct;123(4):199-205. doi: 10.1080/13813455.2017.1302961. Epub 2017 Mar 24.
Papada E, Gioxari A, Amerikanou C, Galanis N, Kaliora AC. An Absorption and Plasma Kinetics Study of Monoterpenes Present in Mastiha Oil in Humans. Foods. 2020 Jul 30;9(8):1019. doi: 10.3390/foods9081019.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MASTIHA OIL-BIO-GR
Identifier Type: -
Identifier Source: org_study_id