NCT04290312

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

February 24, 2020

Last Update Submit

February 27, 2020

Conditions

Keywords

mastiha oil, bioavailability

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

OTHER

As a control to the experimental design, timepoint 0 was considered.

Other: Mastiha oil

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.

Mastiha oil

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 29171157BACKGROUND
  • 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.

    PMID: 28287322BACKGROUND
  • 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.

    PMID: 28273859BACKGROUND
  • 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.

    PMID: 24158653BACKGROUND
  • 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.

    PMID: 24114059BACKGROUND
  • 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.

    PMID: 28969111BACKGROUND
  • 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.

    PMID: 28338348BACKGROUND
  • 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.

MeSH Terms

Interventions

mastiha

Study Officials

  • Andriana Kaliora, Ass. Professor

    Harokopio University

    PRINCIPAL INVESTIGATOR

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

Locations