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

Not Applicable

Not yet recruiting

• Conditions: Hypertriglyceridemia
• Interventions: Dietary Supplement: MastihaOil; Behavioral: nutritional counsel

• Registration Number: NCT06323252
• Lead Sponsor: Harokopio University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Study Start: 2024-04-01
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	MastihaOil	Participants with hypetriglyceridemia will be subjected to nutritional counsel and the intake of 1 soft gel capsule daily for a total of 3 months.
Control group	nutritional counsel	Participants with hypetriglyceridemia will be subjected to nutritional counsel for a total of 3 months.

Primary Outcome Measures

Name	Time	Method
Change in blood triglycerides	3 months	Levels will be evaluated pre and prost intervention in both control and intervention groups