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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04785573
Other study ID # Mastiha_oil_GR_477
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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