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Non Alcoholic Fatty Liver DiseaseMAST4HEALTHNCT03135873

Mastiha Treatment for Obese With NAFLD Diagnosis

A study testing Mastiha in people with Non Alcoholic Fatty Liver Disease, run by Harokopio University at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

NAFLD/NASH is one of the most common complications of obesity and diabetes mellitus in Western populations affecting approximately 50% of diabetics and 76% of obese patients. Due to the lack of specialized treatment, many new efforts focus on exploring alternative, non-pharmacologic means for managing the disease… Read more about this study

Who is it for?
Ages 18 to 67 years
Conditions the study is for
Non Alcoholic Fatty Liver Disease
What is being tested?
Mastiha
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteGreece
Study dates
8 Mar 2017to 8 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed NAFLD/NASH
  • 18 years < Age < 67 years
  • BMI > 30 kg/ m2

Who cannot join

  • Hepatotoxic Medication, Concomitant Liver Disease
  • Decompensated Diabetes Mellitus
  • Dysthyroidism, hypopituitarism, Cushing syndrome / disease
  • Alcohol abuse or drug addiction
  • Clinically or biochemically recognized systemic diseases
  • Pregnancy test, lactation
Show all 12Show fewer
  • Vegan or lacto- and ovo-lacto- vegetarianism
  • Psychiatric or mental disorder
  • Recent loss in body weight or current diet
  • Any use of antioxidant-phytochemical rich supplement, anti-, pre- or pro-biotics within 3 months pre-intervention
  • Changes in drug treatment for e.g. hypertension, diabetes mellitus, 3 months prior or during the 6month intervention
  • Antibiotic treatment during and 2 months prior to screening

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Harokopio University

    Athens, Attica, 17671

Other trials in Greece

About this study

NAFLD/NASH is one of the most common complications of obesity and diabetes mellitus in Western populations affecting approximately 50% of diabetics and 76% of obese patients. Due to the lack of specialized treatment, many new efforts focus on exploring alternative, non-pharmacologic means for managing the disease, including bioactive substances in fruits, vegetables and plants or their products. Mastiha, a natural product of Greece, consists of a great variety of bioactive phytochemical compounds and demonstrates antioxidant, antiinflammatory, antimicrobial and lipid lowering properties. Taking into account the contribution of oxidative stress and inflammation to NAFLD/NASH pathogenesis, the hypothesis that Mastiha could improve disease aspects is investigated. Thus, design of a multicenter (4 centers across Europe), randomized, double-blind, placebo controlled (parallel arm) clinical trial to assess the effect of Mastiha on clinical course of NAFLD/NASH patients has been conducted. The effectiveness of the proposed intervention will be evaluated via clinical and laboratory markers. MAST4HEALTH aims also at exploring gene-diet interactions and at correlating genetic and epigenetic markers with metabolomic and intestinal microbiota profiles pre- and post- intervention. To this end, patients with confirmed NAFLD/NASH will be allocated to either verum or placebo group. Duration of the intervention will be 6 months and the dosage applied will be 2.1 g daily. NAFLD/NASH diagnosis will be confirmed by MS scanning and the sensitive LiverMultiScan technique. Anthropometric, demographic data, body composition, dietary habits, physical activity, family history and smoking status will be assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation, as well as epigenetic and metabolomic profiles will be assessed in blood samples, while the metagenome profile will be examined in stools. Both groups will receive counselling to allow for body weight regulation up to 5%. Compliance will be assessed monthly and side effects will be reported.

Being tested
Mastiha, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MastihaDietary supplement

    Mastiha is a natural product of Greece and has a license of manufactures Foods for Particular Nutritional Uses and of National Organization of Medicines (EOF).

  • PlaceboDietary supplement

    Placebo is designed to have identical characteristics with verum.

Study groups in NCT03135873
Study groupRoleWhat they receive
MastihaActive comparatorThis arm of patients will receive natural Mastiha supplements at a daily dosage of 2.1 g for a 6 month period.
Receives: Dietary Supplement: Mastiha
PlaceboPlacebo comparatorThis arm of patients will receive placebo for a 6 month period.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LIF score

    Improvement in liver histopathology reflected in reduction of the sensitive LIF score

    Measured: 6 months

Secondary outcomes (7)

  1. NAFLD/NASH-related laboratory markers

    Liver enzymes improvement, inflammation and oxidative stress markers improvement (e.g. IL-6, IL-10, TNF-α, GSH, Gpx), lipid profile improvement, insulin sensitivity improvement pre- and post- intervention in each intervention arm.

    Measured: 6 months

  2. Anthropometric characteristics

    BMI pre- and post- intervention in each intervention arm.

    Measured: 6 months

  3. Genetic profile

    Profiles with a comprehensive set of genetic variants to look for markers implicated in response to Mastiha treatment.

    Measured: 6 months

  4. Metabolomic profile

    Quantification of endogenous metabolites from different compound classes

    Measured: 6 months

  5. Metagenomic profile

    Association of gut microbes with Mastiha treatment in NAFLD

    Measured: 6 months

  6. Epigenetic profile

    Identification of the subset of variably methylated regions with low within-individual variability over the six months period of the study to correlate them to treatment.

    Measured: 6 months

  7. Effect of Mastiha on different BMI categories

    Identification of the effect of Mastiha on different obesity categories: Class I obesity (BMI ≤ 35) and Class II or III obesity (BMI> 35)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2017
  2. Study start8 Mar 2017
  3. Primary completion8 Jun 2019
  4. Study completion8 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03135873
Sponsor's protocol ID
MAST4HEALTH (691042)
Acronym
MAST4HEALTH
Status last verified
Apr 2022
First submitted
9 Mar 2017
Last updated
7 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pavlides M, Banerjee R, Sellwood J, Kelly CJ, Robson MD, Booth JC, Collier J, Neubauer S, Barnes E. Multiparametric magnetic resonance imaging predicts clinical outcomes in patients with chronic liver disease. J Hepatol. 2016 Feb;64(2):308-315. doi: 10.1016/j.jhep.2015.10.009. Epub 2015 Nov 10.

    PubMed 26471505

  • Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12.

    PubMed 24036007

  • Hassan K, Bhalla V, El Regal ME, A-Kader HH. Nonalcoholic fatty liver disease: a comprehensive review of a growing epidemic. World J Gastroenterol. 2014 Sep 14;20(34):12082-101. doi: 10.3748/wjg.v20.i34.12082.

    PubMed 25232245

  • Abenavoli L, Milic N, Di Renzo L, Preveden T, Medic-Stojanoska M, De Lorenzo A. Metabolic aspects of adult patients with nonalcoholic fatty liver disease. World J Gastroenterol. 2016 Aug 21;22(31):7006-16. doi: 10.3748/wjg.v22.i31.7006.

    PubMed 27610012

  • Yao H, Qiao YJ, Zhao YL, Tao XF, Xu LN, Yin LH, Qi Y, Peng JY. Herbal medicines and nonalcoholic fatty liver disease. World J Gastroenterol. 2016 Aug 14;22(30):6890-905. doi: 10.3748/wjg.v22.i30.6890.

    PubMed 27570425

  • Dongiovanni P, Romeo S, Valenti L. Genetic Factors in the Pathogenesis of Nonalcoholic Fatty Liver and Steatohepatitis. Biomed Res Int. 2015;2015:460190. doi: 10.1155/2015/460190. Epub 2015 Jul 27.

    PubMed 26273621

  • Fan JG, Cao HX. Role of diet and nutritional management in non-alcoholic fatty liver disease. J Gastroenterol Hepatol. 2013 Dec;28 Suppl 4:81-7. doi: 10.1111/jgh.12244.

    PubMed 24251710

  • Triantafyllou A, Chaviaras N, Sergentanis TN, Protopapa E, Tsaknis J. Chios mastic gum modulates serum biochemical parameters in a human population. J Ethnopharmacol. 2007 Apr 20;111(1):43-9. doi: 10.1016/j.jep.2006.10.031. Epub 2006 Nov 6.

    PubMed 17150319

  • Kanoni S, Kumar S, Amerikanou C, Kurth MJ, Stathopoulou MG, Bourgeois S, Masson C, Kannt A, Cesarini L, Kontoe MS, Milanovic M, Roig FJ, Beribaka M, Campolo J, Jimenez-Hernandez N, Milosevic N, Llorens C, Smyrnioudis I, Francino MP, Milic N, Kaliora AC, Trivella MG, Ruddock MW, Medic-Stojanoska M, Gastaldelli A, Lamont J, Deloukas P, Dedoussis GV, Visvikis-Siest S. Nutrigenetic Interactions Might Modulate the Antioxidant and Anti-Inflammatory Status in Mastiha-Supplemented Patients With NAFLD. Front Immunol. 2021 May 7;12:683028. doi: 10.3389/fimmu.2021.683028. eCollection 2021.

    PubMed 34025683

Questions about this trial

What is this clinical trial studying?

A study testing Mastiha in people with Non Alcoholic Fatty Liver Disease, run by Harokopio University at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LIF score (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03135873, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.

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