Skip to main content
OpenTrials
Completed

NCT Number: NCT05858372

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skylitseio General Hospital

Chios, 82100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chios Mastiha essential oil

Dietary Supplement

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

Other

Placebo

Primary outcomes

  1. Total cholesterol

    Time frame: 8 weeks

    Decrease in total cholesterol serum levels

  2. LDL cholesterol

    Time frame: 8 weeks

    Decrease in LDL cholesterol serum levels

  3. HDL cholesterol

    Time frame: 8 weeks

    Increase in HDL cholesterol serum levels

  4. Triglycerides

    Time frame: 8 weeks

    Decrease in triglycerides serum levels

Secondary outcomes

  1. Glucose

    Time frame: 8 weeks

    Decrease in glucose serum levels

  2. Liver tests

    Time frame: 8 weeks

    Change in liver tests (SGOT, SGPT, gGT)

  3. Renal tests

    Time frame: 8 weeks

    Change in renal tests (BUN, creatinine)

  4. Electrolytes

    Time frame: 8 weeks

    Change in electrolyte levels (sodium, potassium)

  5. Inflammation markers

    Time frame: 8 weeks

    Change in inflammation markers tests (CRP, uric acid)

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Collaborators

  • Skylitseio General Hospital of Chios

Registry information

Official study title

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

Acronym: MASTIHA-OIL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 15, 2023
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.