The Effect of Mastiha Oil in Metabolic Syndrome

NCT ID: NCT04785573

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-03-28

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type ACTIVE_COMPARATOR

Mastiha oil

Intervention Type DIETARY_SUPPLEMENT

1 soft gel capsule of Mastiha oil every day for 3 months

Control group

Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mastiha oil

1 soft gel capsule of Mastiha oil every day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harokopio University

OTHER

Sponsor Role lead

Responsible Party

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Andriana C Kaliora

Associate Professor in Foods and Human Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Harokopio University

Athens, Attica, Greece

Site Status

Andriana Kaliora

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 37329633 (View on PubMed)

Other Identifiers

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Mastiha_oil_GR_477

Identifier Type: -

Identifier Source: org_study_id

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