Mastiha Treatment for Obese With NAFLD Diagnosis

Non Alcoholic Fatty Liver Disease Clinical Trial

— MAST4HEALTH  

Official title:

Mastiha Treatment for Obese With NAFLD Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135873
• Other study ID #: MAST4HEALTH (691042)
• Status: Completed
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: June 8, 2019

Study information

• Verified date: April 2022
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 8, 2019
• Est. primary completion date: June 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Mastiha
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).
• Placebo
Placebo is designed to have identical characteristics with verum.

Locations

Country	Name	City	State
Greece	Harokopio University	Athens	Attica

Sponsors (3)

Lead Sponsor	Collaborator
Harokopio University	National Research Council, Institute of Clinical Physiology, Italy, University of Novi Sad

Country where clinical trial is conducted

Greece, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2006 Nov 6. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LIF score	Improvement in liver histopathology reflected in reduction of the sensitive LIF score	6 months
Secondary	NAFLD/NASH-related laboratory markers	Liver enzymes improvement, inflammation and oxidative stress markers improvement (e.g. IL-6, IL-10, TNF-a, GSH, Gpx), lipid profile improvement, insulin sensitivity improvement pre- and post- intervention in each intervention arm.	6 months
Secondary	Anthropometric characteristics	BMI pre- and post- intervention in each intervention arm.	6 months
Secondary	Genetic profile	Profiles with a comprehensive set of genetic variants to look for markers implicated in response to Mastiha treatment.	6 months
Secondary	Metabolomic profile	Quantification of endogenous metabolites from different compound classes	6 months
Secondary	Metagenomic profile	Association of gut microbes with Mastiha treatment in NAFLD	6 months
Secondary	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.	6 months
Secondary	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)	6 months