HyperlipidemiasMASTIHA-OILNCT05858372
Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers
A study testing Chios Mastiha essential oil in people with Hyperlipidemias and Hypercholesterolemia, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Hypercholesterolemia
- What is being tested?
- Chios Mastiha essential oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Increased total cholesterol >200 mg/dl, in adult volunteers (≥18 years old) of any gender, not amenable or not willing to receive pharmaceutical therapy.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)
A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.
Read the 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.
- Conditions
- Hyperlipidemias, Hypercholesterolemia
- Being tested
- Chios Mastiha essential oil, Placebo
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chios Mastiha essential oilDietary 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
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Chios Mastiha essential oil | Experimental | 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 Receives: Dietary Supplement: Chios Mastiha essential oil |
| Placebo | Placebo comparator | 1 soft gel capsule only 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Decrease in total cholesterol serum levels
Measured: 8 weeks
LDL cholesterol
Decrease in LDL cholesterol serum levels
Measured: 8 weeks
HDL cholesterol
Increase in HDL cholesterol serum levels
Measured: 8 weeks
Triglycerides
Decrease in triglycerides serum levels
Measured: 8 weeks
Secondary outcomes (5)
Glucose
Decrease in glucose serum levels
Measured: 8 weeks
Liver tests
Change in liver tests (SGOT, SGPT, gGT)
Measured: 8 weeks
Renal tests
Change in renal tests (BUN, creatinine)
Measured: 8 weeks
Electrolytes
Change in electrolyte levels (sodium, potassium)
Measured: 8 weeks
Inflammation markers
Change in inflammation markers tests (CRP, uric acid)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Jul 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Skylitseio General Hospital of Chios
- Responsible party
- Principal investigator, Matthaios Didagelos, AHEPA University Hospital
- Investigators
- Athanasios Kartalis, MD, Principal investigator, Skylitseio General Hospital of Chios, GreeceMatthaios Didagelos, MD, PhD, Principal investigator, AHEPA University General Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858372
- Sponsor's protocol ID
- 4-19/02/2020
- Acronym
- MASTIHA-OIL
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 15 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)
- ClinicalTrials.gov ID
- NCT05858372
- Acronym / sponsor ID
- MASTIHA-OIL / 4-19/02/2020
- Conditions
- Hyperlipidemias, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Collaborators
- Skylitseio General Hospital of Chios
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chios Mastiha essential oil | Experimental | Dietary Supplement: Chios Mastiha essential oil1 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 comparator | Other: Placebo1 soft gel capsule only 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Increased total cholesterol >200 mg/dl, in adult volunteers (≥18 years old) of any gender, not amenable or not willing to receive pharmaceutical therapy.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chios Mastiha essential oil1 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 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Total cholesterol
Time frame: 8 weeks
Decrease in total cholesterol serum levels
LDL cholesterol
Time frame: 8 weeks
Decrease in LDL cholesterol serum levels
HDL cholesterol
Time frame: 8 weeks
Increase in HDL cholesterol serum levels
Triglycerides
Time frame: 8 weeks
Decrease in triglycerides serum levels
5 secondary outcomes
Glucose
Time frame: 8 weeks
Liver tests
Time frame: 8 weeks
Renal tests
Time frame: 8 weeks
Electrolytes
Time frame: 8 weeks
Inflammation markers
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemias
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Kartalis, MD principal investigator
Skylitseio General Hospital of Chios, Greece
Matthaios Didagelos, MD, PhD principal investigator
AHEPA University General Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chios Mastiha essential oil in people with Hyperlipidemias and Hypercholesterolemia, run by AHEPA University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.