Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers
MASTIHA-OIL
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFirst Submitted
Initial submission to the registry
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 15, 2023
CompletedMay 15, 2023
May 1, 2023
3 months
May 4, 2023
May 11, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Glucose
8 weeks
Liver tests
8 weeks
Renal tests
8 weeks
Electrolytes
8 weeks
Inflammation markers
8 weeks
Study Arms (2)
Chios Mastiha essential oil
EXPERIMENTAL1 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
PLACEBO COMPARATOR1 soft gel capsule only 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol
Interventions
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
Eligibility Criteria
You may qualify if:
- \- Increased total cholesterol \>200 mg/dl, in adult volunteers (≥18 years old) of any gender, not amenable or not willing to receive pharmaceutical therapy.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AHEPA University Hospitallead
- Skylitseio General Hospital of Chioscollaborator
Study Sites (1)
Skylitseio General Hospital
Chios, 82100, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athanasios Kartalis, MD
Skylitseio General Hospital of Chios, Greece
- PRINCIPAL INVESTIGATOR
Matthaios Didagelos, MD, PhD
AHEPA University General Hospital, Thessaloniki, Greece
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist
Study Record Dates
First Submitted
May 4, 2023
First Posted
May 15, 2023
Study Start
July 1, 2022
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
May 15, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share