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The Effect of Mastiha Oil in Metabolic Syndrome

H

Harokopio University

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Mastiha oil

Study type

Interventional

Funder types

Other

Identifiers

NCT04785573
Mastiha_oil_GR_477

Details and patient eligibility

About

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.

Enrollment

94 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

94 participants in 2 patient groups

Intervention group
Active Comparator group
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.
Treatment:
Dietary Supplement: Mastiha oil
Control group
No Intervention group
Description:
Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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