| Registry | NCT03135873, acronym MAST4HEALTH |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 100 (Actual) |
| Sponsor | Harokopio University (Other); collaborators: University of Novi Sad, National Research Council, Institute of Clinical Physiology, Italy |
| Conditions | Non Alcoholic Fatty Liver Disease |
| Interventions | Mastiha, Placebo (Dietary supplement) |
| Dates | start 2017-03-08, primary completion 2019-06-08, completion 2019-06-08, first posted 2017-05-01, last updated 2022-04-07 |
| Locations | 1 site in Greece |
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All trials for Non Alcoholic Fatty Liver Disease All trials of Mastiha All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mastiha | Active comparator | Dietary Supplement: Mastiha | This arm of patients will receive natural Mastiha supplements at a daily dosage of 2.1 g for a 6 month period. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo | This arm of patients will receive placebo for a 6 month period. |
Sex: All, ages: 18 Years to 67 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Harokopio University | Athens, Attica | Greece |