The Effect of Mastiha Oil in Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Mastiha oil
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- 30 years < Age < 75 years
- BMI > 25 kg/ m2
- Metabolic Syndrome
Exclusion Criteria:
- Hepatotoxic Medication
- Diabetes Mellitus
- Dysthyroidism, hypopituitarism, Cushing syndrome / disease
- Pregnancy, lactation
- Psychiatric or mental disorder
- Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, nti-, pre- or pro-biotics within 3 months pre-intervention
Sites / Locations
- Harokopio University
- Andriana Kaliora
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months.
Outcomes
Primary Outcome Measures
Change in blood total cholesterol
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in insulin sensitivity
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood triglycerides
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood LDL
Levels will be evaluated pre and prost intervention in both control and intervention groups
Secondary Outcome Measures
Change in blood CRP
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood MPO
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood IL-6
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood antioxidant potential
Levels will be evaluated pre and prost intervention in both control and intervention groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04785573
Brief Title
The Effect of Mastiha Oil in Metabolic Syndrome
Official Title
The Effect of Mastiha Oil in Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
March 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mastiha oil
Intervention Description
1 soft gel capsule of Mastiha oil every day for 3 months
Primary Outcome Measure Information:
Title
Change in blood total cholesterol
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
Title
Change in insulin sensitivity
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
Title
Change in blood triglycerides
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
Title
Change in blood LDL
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in blood CRP
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
Title
Change in blood MPO
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
Title
Change in blood IL-6
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
Title
Change in blood antioxidant potential
Description
Levels will be evaluated pre and prost intervention in both control and intervention groups
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Harokopio University
City
Athens
State/Province
Attica
ZIP/Postal Code
17671
Country
Greece
Facility Name
Andriana Kaliora
City
Athens
ZIP/Postal Code
17671
Country
Greece
12. IPD Sharing Statement
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The Effect of Mastiha Oil in Metabolic Syndrome
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