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Completed

NCT Number: NCT04785573

The Effect of Mastiha Oil in Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mastiha oil

Dietary Supplement

1 soft gel capsule of Mastiha oil every day for 3 months

Primary outcomes

  1. Change in blood total cholesterol

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

  2. Change in insulin sensitivity

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

  3. Change in blood triglycerides

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

  4. Change in blood LDL

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

Secondary outcomes

  1. Change in blood CRP

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

  2. Change in blood MPO

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

  3. Change in blood IL-6

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

  4. Change in blood antioxidant potential

    Time frame: 3 months

    Levels will be evaluated pre and prost intervention in both control and intervention groups

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 8, 2021
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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