Absorption and Bioavailability of Major Monoterpenes in Mastiha Oil; a Kinetic Study in Humans.
1 other identifier
interventional
9
1 country
1
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 (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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedFebruary 28, 2020
February 1, 2020
2.1 years
February 24, 2020
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma concentrations of monoterpenes
The monoterpenes will be identified and quantified in plasma samples applying GC-MS-MS. Data will be presented through study completion in plasma concentration (μg/L).
24 hours
Study Arms (1)
Mastiha oil
OTHERAs a control to the experimental design, timepoint 0 was considered.
Interventions
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
You may qualify if:
- Age: 20-40 years old
- BMI: 18.5-24.9 kg/m2
You may not qualify if:
- Obesity
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harokopio University
Athens, Attica, 17671, Greece
Related Publications (8)
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.
PMID: 29171157BACKGROUNDAbidi 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.
PMID: 28287322BACKGROUNDJ 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.
PMID: 28273859BACKGROUNDGarcia-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.
PMID: 24158653BACKGROUNDKanellos 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.
PMID: 24114059BACKGROUNDSubramaniyan 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.
PMID: 28969111BACKGROUNDSaidi 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.
PMID: 28338348BACKGROUNDPapada 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.
PMID: 32751415DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Andriana Kaliora, Ass. Professor
Harokopio University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor in Foods and Human Nutrition
Study Record Dates
First Submitted
February 24, 2020
First Posted
February 28, 2020
Study Start
February 1, 2018
Primary Completion
February 24, 2020
Study Completion
February 24, 2020
Last Updated
February 28, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share