NCT04785573

The Effect of Mastiha Oil in Metabolic Syndrome

Completed NA Last updated 25 April 2023

What this trial tests

NA trial testing Mastiha oil in Metabolic Syndrome in 94 participants. Completed in 28 March 2023.

Timeline

1 March 2021

Primary endpoint
28 September 2022

28 March 2023

Quick facts

Lead sponsor	Harokopio University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	94
Start date	1 March 2021
Primary completion	28 September 2022
Estimated completion	28 March 2023
Sites	2 locations across Greece

Drugs / interventions tested

• Mastiha oil

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Harokopio University

Who can join

Adults 30 to 75, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Chios mastiha essential oil exhibits antihypertensive, hypolipidemic and anti-obesity effects in metabolically unhealthy adults - a randomized controlled trial.
   Gioxari A, Amerikanou C, Valsamidou E, Kleftaki SA, et al · · 2023 · cited 14× · PMID 37329633 · DOI 10.1016/j.phrs.2023.106821
2. Vanadium, cobalt, zinc, and rubidium are associated with markers of inflammation and oxidative stress in a Greek population with obesity.
   Amerikanou C, Kleftaki SA, Karavoltsos S, Tagkouli D, et al · · 2023 · cited 7× · PMID 38075040 · DOI 10.3389/fendo.2023.1265310
3. Peripheral inflammation is linked with emotion and mental health in people with obesity. A "head to toe" observational study.
   Amerikanou C, Valsamidou E, Kleftaki SA, Gioxari A, et al · · 2023 · cited 7× · PMID 37529617 · DOI 10.3389/fendo.2023.1197648
4. Mental Health Component Scale Is Positively Associated with Riboflavin Intake in People with Central Obesity.
   Amerikanou C, Gioxari A, Kleftaki SA, Valsamidou E, et al · · 2023 · cited 3× · PMID 37892539 · DOI 10.3390/nu15204464