A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2024
CompletedFirst Posted
Study publicly available on registry
March 21, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMarch 21, 2024
March 1, 2024
1.6 years
March 14, 2024
March 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in blood triglycerides
Levels will be evaluated pre and prost intervention in both control and intervention groups
3 months
Study Arms (2)
Intervention group
ACTIVE COMPARATORParticipants 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
ACTIVE COMPARATORParticipants with hypetriglyceridemia will be subjected to nutritional counsel for a total of 3 months.
Interventions
1 soft gel capsule of Mastiha oil every day for 3 months
Eligibility Criteria
You may qualify if:
- years \< Age \< 75 years Hypetriglyceridemia A stable weight for ≥ 3 months pre-intervention An unchanged treatment regimen for ≥ 6 months pre-intervention
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor in Foods and Human Nutrition
Study Record Dates
First Submitted
March 14, 2024
First Posted
March 21, 2024
Study Start
April 1, 2024
Primary Completion
October 30, 2025
Study Completion
October 30, 2025
Last Updated
March 21, 2024
Record last verified: 2024-03