NCT03135873

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

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

March 8, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2019

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

March 9, 2017

Last Update Submit

April 6, 2022

Conditions

Non Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • LIF score

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

    6 months

Secondary Outcomes (7)

  • NAFLD/NASH-related laboratory markers

    6 months

  • Anthropometric characteristics

    6 months

  • Genetic profile

    6 months

  • Metabolomic profile

    6 months

  • Metagenomic profile

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Mastiha

ACTIVE COMPARATOR

This arm of patients will receive natural Mastiha supplements at a daily dosage of 2.1 g for a 6 month period.

Dietary Supplement: Mastiha

Placebo

PLACEBO COMPARATOR

This arm of patients will receive placebo for a 6 month period.

Dietary Supplement: Placebo

Interventions

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).

Mastiha
PlaceboDIETARY_SUPPLEMENT

Placebo is designed to have identical characteristics with verum.

Placebo

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harokopio University

Athens, Attica, 17671, Greece

Location

Related Publications (9)

  • 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.

    PMID: 26471505BACKGROUND

  • 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.

    PMID: 24036007BACKGROUND

  • 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.

    PMID: 25232245BACKGROUND

  • 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.

    PMID: 27610012BACKGROUND

  • 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.

    PMID: 27570425BACKGROUND

  • 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.

    PMID: 26273621BACKGROUND

  • 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.

    PMID: 24251710BACKGROUND

  • 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.

    PMID: 17150319BACKGROUND

  • 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.

    PMID: 34025683DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

mastiha

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • G V DEDOUSIS, PROF.

    Harokopio University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Foods and Human Nutrition

Study Record Dates

First Submitted

March 9, 2017

First Posted

May 1, 2017

Study Start

March 8, 2017

Primary Completion

June 8, 2019

Study Completion

June 8, 2019

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations

GR(1)