The Effect of Mastiha Oil in Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Mastiha oil

• Registration Number: NCT04785573
• Lead Sponsor: Harokopio University

Brief 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. 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

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study Start: 2021-03-01
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Primary Completion: 2022-09-28
• Study Completion: 2023-03-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Mastiha oil	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.

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	3 months	Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood LDL	3 months	Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood total cholesterol	3 months	Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood triglycerides	3 months	Levels will be evaluated pre and prost intervention in both control and intervention groups

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Harokopio University; 🇬🇷 Athens, Attica, Greece

Andriana Kaliora; 🇬🇷 Athens, Greece