Skylitseio General Hospital
Chios, 82100, Greece
NCT Number: NCT05858372
A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chios, 82100, Greece
Background Chios Mastiha essential oil (CMO) is a natural product extracted from the resin of Mastiha, possessing antioxidant, anti-microbial, anti-ulcer,anti-neoplasmatic and cholesterol lowering capabilities in vitro, and its hypolipidemic effect was confirmed in animal studies. Yet, there are no randomized, placebo-controlled clinical studies in the literature regarding CMO's hypolipidemic effects in humans.
Design A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.
Methods 192 healthy volunteers were screened and eventually 160 of them with total cholesterol> 200 mg/dl participated in the study. They were randomized with a 2:1 ratio of receiving CMO capsules (containing 200 mg mastiha oil per capsule) and placebo for a total of 8 weeks respectively. 113 patients received CMO and 47 were randomized in the control group, and all of them completed the follow-up period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 soft gel capsule containing 200 mg of CMO and 100 mg of other excipients being medium chain triglycerides, while the shell was made of bovine gelatin and glycerol
Placebo
Time frame: 8 weeks
Decrease in total cholesterol serum levels
Time frame: 8 weeks
Decrease in LDL cholesterol serum levels
Time frame: 8 weeks
Increase in HDL cholesterol serum levels
Time frame: 8 weeks
Decrease in triglycerides serum levels
Time frame: 8 weeks
Decrease in glucose serum levels
Time frame: 8 weeks
Change in liver tests (SGOT, SGPT, gGT)
Time frame: 8 weeks
Change in renal tests (BUN, creatinine)
Time frame: 8 weeks
Change in electrolyte levels (sodium, potassium)
Time frame: 8 weeks
Change in inflammation markers tests (CRP, uric acid)
AHEPA University Hospital
Other
Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)
Acronym: MASTIHA-OIL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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