NCT04785573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

February 16, 2021

Last Update Submit

April 24, 2023

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Change in blood CRP

    3 months

  • Change in blood MPO

    3 months

  • Change in blood IL-6

    3 months

  • Change in blood antioxidant potential

    3 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Participants with metabolic disorders will be subjected to nutritional counsel for a total of 3 months.

Interventions

Mastiha oilDIETARY_SUPPLEMENT

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

Intervention group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harokopio University

Athens, Attica, 17671, Greece

Location

Andriana Kaliora

Athens, 17671, Greece

Location

Related Publications (1)

  • Gioxari A, Amerikanou C, Valsamidou E, Kleftaki SA, Tzavara C, Kalaitzopoulou A, Stergiou I, Smyrnioudis I, Kaliora AC. Chios mastiha essential oil exhibits antihypertensive, hypolipidemic and anti-obesity effects in metabolically unhealthy adults - a randomized controlled trial. Pharmacol Res. 2023 Aug;194:106821. doi: 10.1016/j.phrs.2023.106821. Epub 2023 Jun 15.

    PMID: 37329633DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

mastiha

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Foods and Human Nutrition

Study Record Dates

First Submitted

February 16, 2021

First Posted

March 8, 2021

Study Start

March 1, 2021

Primary Completion

September 28, 2022

Study Completion

March 28, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

GR(2)