The Effect of Mastiha Oil in Metabolic Syndrome

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 Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Mastiha oil

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 17671
    • Andriana Kaliora
  • Attica
    • Athens, Attica, Greece, 17671
      • Harokopio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: Mastiha oil; 1 soft gel capsule of Mastiha oil every day for 3 months
No Intervention: Control group; Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood total cholesterol	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Change in insulin sensitivity	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Change in blood triglycerides	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Change in blood LDL	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood CRP	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Change in blood MPO	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Change in blood IL-6	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Change in blood antioxidant potential	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months

Collaborators and Investigators

• Sponsor: Harokopio University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: Mastiha_oil_GR_477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No