Clinical trial NCT05858372: Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers
Official title: Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Hypercholesterolemia
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
Collaborators: name: Skylitseio General Hospital of Chios
First posted: 2023-05-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total cholesterol
timeFrame: 8 weeks
measure: LDL cholesterol
timeFrame: 8 weeks
measure: HDL cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
Secondary outcomes:
measure: Glucose
timeFrame: 8 weeks
measure: Liver tests
timeFrame: 8 weeks
measure: Renal tests
timeFrame: 8 weeks
measure: Electrolytes
timeFrame: 8 weeks
measure: Inflammation markers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chios
country: Greece
facility: Skylitseio General Hospital
Study officials:
affiliation: Skylitseio General Hospital of Chios, Greece
name: Athanasios Kartalis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AHEPA University General Hospital, Thessaloniki, Greece
name: Matthaios Didagelos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: