Metabolic SyndromeNCT04785573
The Effect of Mastiha Oil in Metabolic Syndrome
A study testing Mastiha oil in people with Metabolic Syndrome, run by Harokopio University at 2 sites in Greece.
Trial summary
Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Over 90 compounds have been identified in Mastiha oil, with monoterpenes exhibiting favorable effects in regulating mechanisms of oxidative stress and inflammation. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Mastiha oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Mar 2021to 28 Mar 2023
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 years < Age < 75 years
- Metabolic Syndrome cardiometabolic parameters
- A stable weight for ≥ 3 months pre-intervention
- An unchanged treatment regimen for ≥ 6 months pre-intervention
Who cannot join
- Hepatotoxic Medication
- Untreated Diabetes Mellitus
- Dysthyroidism, hypopituitarism, Cushing syndrome / disease
- Pregnancy, lactation
- Psychiatric or mental disorder
- Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, anti-, pre- or pro-biotics within 3 months pre-intervention
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Harokopio University
Athens, Attica, 17671
Andriana Kaliora
Athens, 17671
About this study
Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Over 90 compounds have been identified in Mastiha oil, with monoterpenes exhibiting favorable effects in regulating mechanisms of oxidative stress and inflammation. The aim of this study is to determine the effect of Mastiha oil in adults with Metabolic Syndrome. 90 participants will be allocated to two groups, (45 in intervention group and 45 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.
The effects of the intervention will be evaluated via clinical and laboratory markers.
- Conditions
- Metabolic Syndrome
- Being tested
- Mastiha oil
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastiha oilDietary supplement
1 soft gel capsule of Mastiha oil every day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Participants with metabolic disorders will be subjected to nutritional counsel and the intake of 1 soft gel capsule daily for a total of 3 months. Receives: Dietary Supplement: Mastiha oil |
| Control group | No intervention | Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood total cholesterol
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Change in insulin sensitivity
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Change in blood triglycerides
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Change in blood LDL
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Secondary outcomes (4)
Change in blood CRP
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Change in blood MPO
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Change in blood IL-6
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Change in blood antioxidant potential
Levels will be evaluated pre and prost intervention in both control and intervention groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Mar 2021
- Primary completion28 Sep 2022
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andriana C Kaliora, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785573
- Sponsor's protocol ID
- Mastiha_oil_GR_477
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gioxari A, Amerikanou C, Valsamidou E, Kleftaki SA, Tzavara C, Kalaitzopoulou A, Stergiou I, Smyrnioudis I, Kaliora AC. Chios mastiha essential oil exhibits antihypertensive, hypolipidemic and anti-obesity effects in metabolically unhealthy adults - a randomized controlled trial. Pharmacol Res. 2023 Aug;194:106821. doi: 10.1016/j.phrs.2023.106821. Epub 2023 Jun 15.
PubMed 37329633
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mastiha Oil in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04785573
- Acronym / sponsor ID
- Mastiha_oil_GR_477
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 8 Mar 2021 (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.
Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Over 90 compounds have been identified in Mastiha oil, with monoterpenes exhibiting favorable effects in regulating mechanisms of oxidative stress and inflammation. The aim of this study is to determine the effect of Mastiha oil in adults with Metabolic Syndrome. 90 participants will be allocated to two groups, (45 in intervention group and 45 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.
The effects of the intervention will be evaluated via clinical and laboratory markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Mastiha oilParticipants with metabolic disorders will be subjected to nutritional counsel and the intake of 1 soft gel capsule daily for a total of 3 months. |
| Control group | No intervention | –Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 30 years < Age < 75 years
- Metabolic Syndrome cardiometabolic parameters
- A stable weight for ≥ 3 months pre-intervention
- An unchanged treatment regimen for ≥ 6 months pre-intervention
Key exclusion criteria (6 listed)
- Hepatotoxic Medication
- Untreated Diabetes Mellitus
- Dysthyroidism, hypopituitarism, Cushing syndrome / disease
- Pregnancy, lactation
- Psychiatric or mental disorder
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 |
|---|---|---|
| Mastiha oil1 soft gel capsule of Mastiha oil every day for 3 months | Dietary supplement | Intervention group |
Primary outcome
Change in blood total cholesterol
Time frame: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in insulin sensitivity
Time frame: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood triglycerides
Time frame: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood LDL
Time frame: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
4 secondary outcomes
Change in blood CRP
Time frame: 3 months
Change in blood MPO
Time frame: 3 months
Change in blood IL-6
Time frame: 3 months
Change in blood antioxidant potential
Time frame: 3 months
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 25 Apr 2023.
- Derived from this study: PubMed 37329633Gioxari A, Amerikanou C, Valsamidou E, Kleftaki SA, Tzavara C, Kalaitzopoulou A, Stergiou I, Smyrnioudis I, Kaliora AC. Chios mastiha essential oil exhibits antihypertensive, hypolipidemic and anti-obesity effects in metabolically unhealthy adults - a randomized controlled trial. Pharmacol Res. 2023 Aug;194:106821. doi: 10.1016/j.phrs.2023.106821. Epub 2023 Jun 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastiha oil in people with Metabolic Syndrome, run by Harokopio University at 2 sites 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 4 inclusion and 6 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Change in blood total cholesterol (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT04785573, which also lists 1 linked publication.
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 25 Apr 2023.