The Effect of Mastiha Oil in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

The Effect of Mastiha Oil in Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785573
• Other study ID #: Mastiha_oil_GR_477
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 28, 2023

Study information

• Verified date: April 2023
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 28, 2023
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Mastiha oil
1 soft gel capsule of Mastiha oil every day for 3 months

Locations

Country	Name	City	State
Greece	Andriana Kaliora	Athens
Greece	Harokopio University	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Harokopio University

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood total cholesterol	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Primary	Change in insulin sensitivity	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Primary	Change in blood triglycerides	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Primary	Change in blood LDL	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Secondary	Change in blood CRP	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Secondary	Change in blood MPO	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Secondary	Change in blood IL-6	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months
Secondary	Change in blood antioxidant potential	Levels will be evaluated pre and prost intervention in both control and intervention groups	3 months