Supervisors info:
Κωνσταντίνος Τούτουζας, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ελένη Κυρίτση, Ομότιμη Καθηγήτρια, Τμήμα Νοσηλευτικής, ΠΑΔΑ
Δημήτριος Τούσουλης, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Summary:
Introduction: Chios Mastiha essential oil (CMO) is a natural product extracted from the resin of Mastiha, possessing antioxidant, anti-microbial, anti-ulcer, anti-neoplasmatic and cholesterol lowering capabilities in vitro, and its hypolipidemic effect was confirmed in animal studies. Yet, there are no randomized, placebo-controlled clinical studies in the literature regarding CMO’s hypolipidemic effects in humans.
Purpose: The purpose of our study was to evaluate the hypolipidemic effect and safety of CMO, on otherwise healthy volunteers with elevated cholesterol levels, who were not on medication with another hypolipidemic factor, or had no clear indication to receive one according to the current guidelines.
Thus, a prospective, randomized, placebo-controlled study was designed in our center to study the hypolipidemic effect of CMO capsules on volunteers with elevated cholesterol. (MASTIHA-OIL study-ClinicalTrials.govID: NCT05858372)
Material and Methods: 160 adult, otherwise healthy volunteers (102 women) with an average age of 52±9 years and total cholesterol> 200 mg/dl were included in our study. Exclusion criteria were treatment with a hypolipidemic factor and the presence of cardiovascular disease. They were randomized with a 2:1 ratio of receiving CMO capsules (200 mg mastiha-oil/capsule) and placebo for 8 weeks respectively. 113 patients received CMO and 47 were randomized in the control group, and all of them completed the follow-up period.
Results: After 8 weeks of CMO administration, total and LDL cholesterol were significantly lower in the CMO compared to the placebo group 215.2±27.5 vs 237.0±27.9 mg/dl (p<0.001) and 135.0±26.1 vs 153.0±23.3 mg/dl (p<0.001) respectively. No gastrointestinal adverse events, liver or renal toxicity were reported. Additionally, in the CMO group total cholesterol was significantly decreased by 20.6 mg/dl (9%) and LDL by 18.1 mg/dl (12%), triglycerides by 21.8 mg/dl (15%) and glucose by 4.6 mg/dl (5%) and HDL was increased by 2.4 mg/dl (5%), compared to their baseline values.
Conclusions: MASTIHA-OIL study showed with statistical significance the efficacy and safety of CMO in reduction of Total and LDL-cholesterol after 8 weeks of administration in otherwise healthy volunteers with elevated cholesterol levels. More multicenter clinical studies need to be organized to establish CMOs role as a hypolipidemic agent.
Keywords:
Mastiha-oil, Chios mastiha, Dyslipidemia, Terpens, Atherosclerosis, Cardiovascular disease
