Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers

AHEPA University Hospital160 enrolled

Overview

A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.

Background 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. Design A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels. Methods 192 healthy volunteers were screened and eventually 160 of them with total cholesterol\> 200 mg/dl participated in the study. They were randomized with a 2:1 ratio of receiving CMO capsules (containing 200 mg mastiha oil per capsule) and placebo for a total of 8 weeks respectively. 113 patients received CMO and 47 were randomized in the control group, and all of them completed the follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Hyperlipidemias Hypercholesterolemia

Interventions

Chios Mastiha essential oilDIETARY_SUPPLEMENT

1 soft gel capsule containing 200 mg of CMO and 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Increased total cholesterol \>200 mg/dl, in adult volunteers (≥18 years old) of any gender, not amenable or not willing to receive pharmaceutical therapy. Exclusion Criteria: * Participation in any other study during the recruitment period * Contribution in the design or accomplishment of the study * Known cardiovascular disease (coronary artery disease, carotid artery disease, peripheral vascular disease, stroke, diabetes mellitus, aortic aneurysm) * Patients in high or very high risk of CVD according to SCORE2 * Subjects amenable to pharmaceutical lipid-lowering regimens according to current guideline, or any other pharmaceutical regimen with hypolipidemic effects

Locations (1)

Skylitseio General Hospital

Chios, Greece

Outcomes

Primary Outcomes

Total cholesterol

Decrease in total cholesterol serum levels

Time frame: 8 weeks

LDL cholesterol

Decrease in LDL cholesterol serum levels

Time frame: 8 weeks

HDL cholesterol

Increase in HDL cholesterol serum levels

Time frame: 8 weeks

Triglycerides

Decrease in triglycerides serum levels

Time frame: 8 weeks

Secondary Outcomes

Glucose

Decrease in glucose serum levels

Time frame: 8 weeks

Liver tests

Change in liver tests (SGOT, SGPT, gGT)

Time frame: 8 weeks

Renal tests

Change in renal tests (BUN, creatinine)

Time frame: 8 weeks

Electrolytes

Change in electrolyte levels (sodium, potassium)

Time frame: 8 weeks

Inflammation markers

Change in inflammation markers tests (CRP, uric acid)

Time frame: 8 weeks

Data from ClinicalTrials.gov

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