Clinical trial NCT02847117: Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults.
Official title: A Bioavailability Study of the Natural Chios Mastiha in Blood and Urine Samples of Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biological Availability
Keywords: Natural Mastiha, Bioavailability
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Mastiha is a natural product from the tree Pistacia lentiscus var. Chia (Anacardiaceae) growing exclusively in the Southern part of Chios Island. It is the natural resinous exudate produced after longitudinal incisions made at close intervals from the base of the trunk up to the thicker branches of the tree. U.S. Food and Drug Administration has classified Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders, skin inflammation and healing (EMA/HMPC/46758/2015).

However, the bioavailability of its microconstituents in human biological samples is still undetermined. To this end, the current study aims to investigate the whether Mastiha's compounds are bioavailable in healthy adults. Twenty apparently healthy men, aged 20-40 years old, will be enrolled based on certain inclusion and exclusion criteria. The staff of the study will provide detailed information regarding the aims, the methods, anticipated benefits and potential hazards of the study and all patients will receive the Patient Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether they want to participate in the protocol. Each patient agreeing to participate will sign an Informed Consent document and the staff will explain to patients that they are under no obligation to enter the trial and that they can withdraw at any time during the trial, without having to give a reason. A copy of the signed Informed Consent will be given to the participant.

After enrollment, the volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count. Then, they will follow a low-phytochemical diet for five days, meaning that they will exclude fruits, vegetables, legumes, coffee, tea, alcoholic beverages and chocolate. On the day of the experiment and after overnight fasting, the volunteers will consume 10g of natural Mastiha and blood samples will be obtained on timepoints 0h, 30min, 1h, 2h, 4h, 6h and 24h after Mastiha intake. Until timepoint 6h, they will be allowed to consume only water. Urine samples will also be collected on timepoints 0h, 4h, 8h and 24h.

After collection, the phenolic and terpenoid content or metabolites of Mastiha will be identified in plasma samples applying LC-HRMS. Additionally, the metabolomic profile will be assessed in plasma samples with LC-HRMS and in urine samples with NMR-based metabolomics. Oxidative stress will be evaluated through the CuSO4 technique and oxidised LDL levels in serum samples, as well as F-2 isoprostanes in urine samples.


Eligibility criteria: Inclusion Criteria:

* Age: 20-40 years old
* BMI: 18.5-24.9 kg/m2

Exclusion Criteria:

* BMI \> 25 kg/m2
* Alcohol or drug abuse
* Medication, vitamin or inorganic supplements
* Vegan or macrobiotic diet before and during the study
* Gastrointestinal diseases, such as IBD, peptic ulcer or GI cancer

Primary outcomes:
measure: Phenolic and terpenoid content or metabolites of Mastiha identification
timeFrame: The phenolic and terpenoid content or metabolites of Mastiha will be identified in plasma samples applying LC-HRMS. Data will be presented through study completion, an average of 1 year.
measure: Targeted and untargeted metabolic profile assessment
timeFrame: Plasma metabolites assessment with GC-MS, LC-HRMS and urine metabolites assessment with NMR will take place . Data will be presented through study completion, an average of 1 year.
Secondary outcomes:
measure: Oxidative stress assessment
timeFrame: Serum resistance to oxidation will be assessed through the CuSO4 technique, oxidised LDL levels and uric acid levels. F-2 isoprostanes determination will take place in urine samples. Data will be presented through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
Study officials:
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