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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperlipidemias, Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Chios Mastiha essential oil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chios Mastiha essential oil<br>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 | Dietary Supplement: Chios Mastiha essential oil<br>* 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<br>|
| Placebo Comparator: Placebo<br>1 soft gel capsule only 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Decrease in total cholesterol serum levels | 8 weeks | 
| LDL cholesterol | Decrease in LDL cholesterol serum levels | 8 weeks | 
| HDL cholesterol | Increase in HDL cholesterol serum levels | 8 weeks | 
| Triglycerides | Decrease in triglycerides serum levels | 8 weeks | 

Secondary Outcome Measures

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