Other Clinical Trial - Mastiha Treatment for Obese With NAFLD Diagnosis

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT03135873
Study type	Interventional
Source	Harokopio University
Contact
Status	Completed
Phase	N/A
Start date	March 8, 2017
Completion date	June 8, 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02248311` - "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population	N/A
Completed	`NCT01277237` - The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease	Phase 3
Active, not recruiting	`NCT04442620` - Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity	N/A
Completed	`NCT01999101` - Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients	Phase 2
Completed	`NCT01327443` - Exercise Versus Diet in the Treatment of Nonalcoholic Fatty Liver Disease	N/A
Active, not recruiting	`NCT01482065` - The Sleep, Liver Evaluation and Effective Pressure Study	N/A
Completed	`NCT02686476` - Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes	N/A
Completed	`NCT02820285` - Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH	N/A
Completed	`NCT01556113` - Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease	N/A
Recruiting	`NCT06080386` - UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)
Terminated	`NCT02134522` - The Role of Obstructive Sleep Apnea in Children With Fatty Liver Disease	N/A
Completed	`NCT01553500` - Glucomannan Effects on Children With Non-alcoholic Fatty Liver Disease	Phase 2
Completed	`NCT05426382` - A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease	N/A
Completed	`NCT03300661` - Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine	N/A
Not yet recruiting	`NCT02178839` - The Effect of Oral β- Glucan Supplement on Appetite and Insulin Resistance in Non Alcoholic Fatty Liver Disease	N/A
Recruiting	`NCT02038387` - Prospective Clinical Study of the Role of the Immune Response, in Relation to Diet, in Patients Affected by Either Chronic Hepatitis C Virus (HCV) Infection or Non Alcoholic Fatty Liver Disease (NAFLD)	N/A
Completed	`NCT01634048` - The Effect of Protein-enriched Diet on Body Composition and Appetite	N/A
Completed	`NCT01874249` - Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease	N/A
Completed	`NCT01966627` - Genetics of Fatty Liver Disease in Children	N/A
Terminated	`NCT01842282` - Amlexanox for Type 2 Diabetes and Obesity	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Mastiha Treatment for Obese With NAFLD Diagnosis — MAST4HEALTH

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms