The Effect of Mastiha Oil in Metabolic Syndrome

Study Overview
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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.

Official Title
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The Effect of Mastiha Oil in Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Mastiha oil


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |