Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults.

NCT02847117 | Completed

• 1 other identifier: Mastiha BIO-GR (304)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Biological Availability

Keywords

Natural Mastiha, Bioavailability

Outcome Measures

Primary Outcomes (2)

• Phenolic and terpenoid content or metabolites of Mastiha identification

  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.

• Targeted and untargeted metabolic profile assessment

  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 (1)

• Oxidative stress assessment

  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.

Study Arms (1)

Mastiha

OTHER

Other: Mastiha

Interventions

Mastiha OTHER

The volunteers 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, will be allowed to consume only water. Urine samples will also be collected on timepoints 0h, 4h, 8h and 24h.

Mastiha

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harokopio University: lead

Study Sites (1)

Harokopio University

Athens, 17671, Greece

Location

Related Publications (16)

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  PMID: 12018027 BACKGROUND

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  PMID: 10082788 BACKGROUND

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  PMID: 22963623 BACKGROUND

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  PMID: 11328766 BACKGROUND

• Inouye S, Yamaguchi H, Takizawa T. Screening of the antibacterial effects of a variety of essential oils on respiratory tract pathogens, using a modified dilution assay method. J Infect Chemother. 2001 Dec;7(4):251-4. doi: 10.1007/s101560170022.

  PMID: 11810593 BACKGROUND

• Ohno T, Kita M, Yamaoka Y, Imamura S, Yamamoto T, Mitsufuji S, Kodama T, Kashima K, Imanishi J. Antimicrobial activity of essential oils against Helicobacter pylori. Helicobacter. 2003 Jun;8(3):207-15. doi: 10.1046/j.1523-5378.2003.00146.x.

  PMID: 12752733 BACKGROUND

• Ding Y, Nguyen HT, Kim SI, Kim HW, Kim YH. The regulation of inflammatory cytokine secretion in macrophage cell line by the chemical constituents of Rhus sylvestris. Bioorg Med Chem Lett. 2009 Jul 1;19(13):3607-10. doi: 10.1016/j.bmcl.2009.04.129. Epub 2009 May 3.

  PMID: 19447618 BACKGROUND

• Rodrigues TG, Fernandes A Jr, Sousa JP, Bastos JK, Sforcin JM. In vitro and in vivo effects of clove on pro-inflammatory cytokines production by macrophages. Nat Prod Res. 2009;23(4):319-26. doi: 10.1080/14786410802242679.

  PMID: 19296372 BACKGROUND

• Andrikopoulos NK, Kaliora AC, Assimopoulou AN, Papapeorgiou VP. Biological activity of some naturally occurring resins, gums and pigments against in vitro LDL oxidation. Phytother Res. 2003 May;17(5):501-7. doi: 10.1002/ptr.1185.

  PMID: 12748987 BACKGROUND

• Gioxari A, Kaliora AC, Papalois A, Agrogiannis G, Triantafillidis JK, Andrikopoulos NK. Pistacia lentiscus resin regulates intestinal damage and inflammation in trinitrobenzene sulfonic acid-induced colitis. J Med Food. 2011 Nov;14(11):1403-11. doi: 10.1089/jmf.2010.0240. Epub 2011 May 25.

  PMID: 21612460 BACKGROUND

• Papalois A, Gioxari A, Kaliora AC, Lymperopoulou A, Agrogiannis G, Papada E, Andrikopoulos NK. Chios mastic fractions in experimental colitis: implication of the nuclear factor kappaB pathway in cultured HT29 cells. J Med Food. 2012 Nov;15(11):974-83. doi: 10.1089/jmf.2012.0018. Epub 2012 Aug 14.

  PMID: 22891614 BACKGROUND

• Williamson G, Manach C. Bioavailability and bioefficacy of polyphenols in humans. II. Review of 93 intervention studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):243S-255S. doi: 10.1093/ajcn/81.1.243S.

  PMID: 15640487 BACKGROUND

• Kountouri AM, Mylona A, Kaliora AC, Andrikopoulos NK. Bioavailability of the phenolic compounds of the fruits (drupes) of Olea europaea (olives): impact on plasma antioxidant status in humans. Phytomedicine. 2007 Oct;14(10):659-67. doi: 10.1016/j.phymed.2007.06.001. Epub 2007 Sep 17.

  PMID: 17870451 BACKGROUND

• Kanellos PT, Kaliora AC, Liaskos C, Tentolouris NK, Perrea D, Karathanos VT. A study of glycemic response to Corinthian raisins in healthy subjects and in type 2 diabetes mellitus patients. Plant Foods Hum Nutr. 2013 Jun;68(2):145-8. doi: 10.1007/s11130-013-0348-y.

  PMID: 23564595 BACKGROUND

• Lemonakis N, Magiatis P, Kostomitsopoulos N, Skaltsounis AL, Tamvakopoulos C. Oral administration of chios mastic gum or extracts in mice: quantification of triterpenic acids by liquid chromatography-tandem mass spectrometry. Planta Med. 2011 Nov;77(17):1916-23. doi: 10.1055/s-0031-1279996. Epub 2011 Aug 25.

  PMID: 21870323 BACKGROUND

MeSH Terms

Interventions

mastiha

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 & Human Nutrition"

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 10, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)