MASTIHA-OIL: Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers

• Sponsor: AHEPA University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05858372
• Collaborator: Skylitseio General Hospital of Chios (Other)
• Enrollment: 160
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 53.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias; Hypercholesterolemia	Dietary Supplement: Chios Mastiha essential oil; Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)
• Actual Study Start Date: Jul 1, 2022
• Actual Primary Completion Date: Sep 30, 2022
• Actual Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
Placebo Comparator: 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	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Total cholesterol [8 weeks]

   Decrease in total cholesterol serum levels

2. LDL cholesterol [8 weeks]

   Decrease in LDL cholesterol serum levels

3. HDL cholesterol [8 weeks]

   Increase in HDL cholesterol serum levels

4. Triglycerides [8 weeks]

   Decrease in triglycerides serum levels

Secondary Outcome Measures

1. Glucose [8 weeks]

   Decrease in glucose serum levels

2. Liver tests [8 weeks]

   Change in liver tests (SGOT, SGPT, gGT)

3. Renal tests [8 weeks]

   Change in renal tests (BUN, creatinine)

4. Electrolytes [8 weeks]

   Change in electrolyte levels (sodium, potassium)

5. Inflammation markers [8 weeks]

   Change in inflammation markers tests (CRP, uric acid)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skylitseio General Hospital	Chios		Greece	82100

Sponsors and Collaborators

• AHEPA University Hospital
• Skylitseio General Hospital of Chios

Investigators

• Principal Investigator: Athanasios Kartalis, MD, Skylitseio General Hospital of Chios, Greece
• Principal Investigator: Matthaios Didagelos, MD, PhD, AHEPA University General Hospital, Thessaloniki, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthaios Didagelos, Cardiologist, AHEPA University Hospital
• ClinicalTrials.gov Identifier: NCT05858372
• Other Study ID Numbers: 4-19/02/2020
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypercholesterolemia; Hyperlipidemias

Study Results

No Results Posted as of May 15, 2023