Metabolic Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMastiha oil
1 soft gel capsule of Mastiha oil every day for 3 months
Sponsors
Harokopio University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 insulin sensitivity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in blood CRP | 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 IL-6 | 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 |
Countries
Greece
Outcome results
None listed