Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Mastiha Treatment for Obese With NAFLD Diagnosis
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.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo capsules | Arm Label: 1000 mg Epeleuton; Type: EXPERIMENTAL; Interventions: Drug: Epeleuton | Arm Label: 2000 mg Epeleuton; Type: EXPERIMENTAL; Interventions: Drug: Epeleuton | Intervention Type: OTHER; Name: Placebo capsules; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Epeleuton; Assigned to Arm(s): 1000 mg Epeleuton, 2000 mg Epeleuton
B: Arm Label: TREATED GROUP; Type: EXPERIMENTAL; Interventions: Drug: Hydroxytyrosol plus Vitamin E | Arm Label: PLACEBO GROUP; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Hydroxytyrosol plus Vitamin E; Assigned to Arm(s): TREATED GROUP | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): PLACEBO GROUP
C: Arm Label: Prebiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Prebiotic oligofructose | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo maltodextrin | Intervention Type: DIETARY_SUPPLEMENT; Name: Prebiotic oligofructose; Assigned to Arm(s): Prebiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo maltodextrin; Assigned to Arm(s): Placebo
D: Arm Label: Mastiha; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Mastiha | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Mastiha; Assigned to Arm(s): Mastiha | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D