NCT05858372

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

Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: AHEPA University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Hyperlipidemias
• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Chios Mastiha essential oil	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
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2023-05-15
• Last updated: 2023-05-15

Locations

1 site across 1 country: Greece