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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type ACTIVE_COMPARATOR

MastihaOil

Intervention Type DIETARY_SUPPLEMENT

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

Control group

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

Group Type ACTIVE_COMPARATOR

nutritional counsel

Intervention Type BEHAVIORAL

nutritional counsel

Interventions

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MastihaOil

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

Intervention Type DIETARY_SUPPLEMENT

nutritional counsel

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No