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

Hypercholesterolemia Clinical Trial

— MASTIHA-OIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858372
• Other study ID #: 4-19/02/2020
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemias

Intervention

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

Locations

Country	Name	City	State
Greece	Skylitseio General Hospital	Chios

Sponsors (2)

Lead Sponsor	Collaborator
AHEPA University Hospital	Skylitseio General Hospital of Chios

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol	Decrease in total cholesterol serum levels	8 weeks
Primary	LDL cholesterol	Decrease in LDL cholesterol serum levels	8 weeks
Primary	HDL cholesterol	Increase in HDL cholesterol serum levels	8 weeks
Primary	Triglycerides	Decrease in triglycerides serum levels	8 weeks
Secondary	Glucose	Decrease in glucose serum levels	8 weeks
Secondary	Liver tests	Change in liver tests (SGOT, SGPT, gGT)	8 weeks
Secondary	Renal tests	Change in renal tests (BUN, creatinine)	8 weeks
Secondary	Electrolytes	Change in electrolyte levels (sodium, potassium)	8 weeks
Secondary	Inflammation markers	Change in inflammation markers tests (CRP, uric acid)	8 weeks