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

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemias
• Interventions: Other: Placebo; Dietary Supplement: Chios Mastiha essential oil

• Registration Number: NCT05858372
• Lead Sponsor: AHEPA University Hospital

Brief 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.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 soft gel capsule only 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol
Chios Mastiha essential oil	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

Primary Outcome Measures

Name	Time	Method
HDL cholesterol	8 weeks	Increase in HDL cholesterol serum levels
Total cholesterol	8 weeks	Decrease in total cholesterol serum levels
LDL cholesterol	8 weeks	Decrease in LDL cholesterol serum levels
Triglycerides	8 weeks	Decrease in triglycerides serum levels

Secondary Outcome Measures

Name	Time	Method
Inflammation markers	8 weeks	Change in inflammation markers tests (CRP, uric acid)
Electrolytes	8 weeks	Change in electrolyte levels (sodium, potassium)
Glucose	8 weeks	Decrease in glucose serum levels
Liver tests	8 weeks	Change in liver tests (SGOT, SGPT, gGT)
Renal tests	8 weeks	Change in renal tests (BUN, creatinine)

Trial Locations

Locations (1)

Skylitseio General Hospital; 🇬🇷 Chios, Greece