Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers (MASTIHA-OIL)

AHEPA University Hospital

Status: Completed

Conditions: Hyperlipidemias; Hypercholesterolemia

Treatments: Dietary Supplement: Chios Mastiha essential oil; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05858372

4-19/02/2020

Details and patient eligibility

About

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

Full description

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

Chios Mastiha essential oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: Chios Mastiha essential oil

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo