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NCT06323252 Clinical Trial

A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

Official title:
A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06323252
Other study ID # MastihaOil-HT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date October 30, 2025

Study information
Verified date March 2024
Source Harokopio University
Contact Andriana C Kaliora, Ass. Professor
Phone +30 2109549226
Email akaliora@hua.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date October 30, 2025
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria: - 30 years < Age < 75 years Hypetriglyceridemia 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• MastihaOil
1 soft gel capsule of Mastiha oil every day for 3 months
Behavioral:
• nutritional counsel
nutritional counsel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Harokopio University

Outcome
Type Measure Description Time frame Safety issue
Primary Change in blood triglycerides Levels will be evaluated pre and prost intervention in both control and intervention groups 3 months
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