Clinical trial NCT03135873: Mastiha Treatment for Obese With NAFLD Diagnosis
Official title: Mastiha Treatment for Obese With NAFLD Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: University of Novi Sad
name: National Research Council, Institute of Clinical Physiology, Italy
First posted: 2017-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: LIF score
timeFrame: 6 months
Secondary outcomes:
measure: NAFLD/NASH-related laboratory markers
timeFrame: 6 months
measure: Anthropometric characteristics
timeFrame: 6 months
measure: Genetic profile
timeFrame: 6 months
measure: Metabolomic profile
timeFrame: 6 months
measure: Metagenomic profile
timeFrame: 6 months
measure: Epigenetic profile
timeFrame: 6 months
measure: Effect of Mastiha on different BMI categories
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
state: Attica
Study officials:
affiliation: Harokopio University
name: G V DEDOUSIS, PROF.
role: STUDY_DIRECTOR
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