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

Harokopio University

Status: Not yet enrolling

Conditions: Hypertriglyceridemia

Treatments: Behavioral: nutritional counsel; Dietary Supplement: MastihaOil

Study type: Interventional

Funder types: Other

Identifiers

NCT06323252

MastihaOil-HT

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: MastihaOil

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: nutritional counsel