MAST4HEALTH: Mastiha Treatment for Obese With NAFLD Diagnosis

• Sponsor: Harokopio University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03135873
• Collaborator: University of Novi Sad (Other), National Research Council, Institute of Clinical Physiology, Italy (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Dietary Supplement: Mastiha; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mastiha Treatment for Obese With NAFLD Diagnosis
• Actual Study Start Date: Mar 8, 2017
• Actual Primary Completion Date: Jun 8, 2019
• Actual Study Completion Date: Jun 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mastiha 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; 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 Comparator: Placebo This arm of patients will receive placebo for a 6 month period.	Dietary Supplement: Placebo; Placebo is designed to have identical characteristics with verum.

Outcome Measures

Primary Outcome Measures

1. LIF score [6 months]

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

Secondary Outcome Measures

1. NAFLD/NASH-related laboratory markers [6 months]

   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.

2. Anthropometric characteristics [6 months]

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

3. Genetic profile [6 months]

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

4. Metabolomic profile [6 months]

   Quantification of endogenous metabolites from different compound classes

5. Metagenomic profile [6 months]

   Association of gut microbes with Mastiha treatment in NAFLD

6. Epigenetic profile [6 months]

   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.

7. Effect of Mastiha on different BMI categories [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 67 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harokopio University	Athens	Attica	Greece	17671

Sponsors and Collaborators

• Harokopio University
• University of Novi Sad
• National Research Council, Institute of Clinical Physiology, Italy

Investigators

• Study Director: G V DEDOUSIS, PROF., Harokopio University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Abenavoli L, Milic N, Di Renzo L, Preveden T, Medić-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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Andriana C Kaliora, Assistant Professor in Foods and Human Nutrition, Harokopio University
• ClinicalTrials.gov Identifier: NCT03135873
• Other Study ID Numbers: MAST4HEALTH (691042)
• First Posted: May 1, 2017
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Apr 7, 2022