EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME
NCT ID: NCT06673914
Last Updated: 2024-11-05
Study Results
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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ACTIVE_NOT_RECRUITING
NA
34 participants
INTERVENTIONAL
2024-11-01
2025-01-15
Brief Summary
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Detailed Description
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Sub-objectives of the study;
Determining the presence of inflammation in patiens with metabolic syndrome Determination of the effect of diet and diet combined with oleuropein on both fasting blood glucose, insulin and blood lipid profile.
Determination of both anti-inflammatory and antidiabetic effects of oleuropein. Determination of the effect of diet and diet combined with oleuropein on anthropometric measurements.
The aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic syndrome as a result of the medical nutrition therpy with consumption of olive leaf extract (2 times a day) that has been contain 100 mg oleuropein for 6 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group: Diet Group
Control Group: Diet Group Among those who applied to the clinic, those who want to follow their diet will be randomized into this group. Patients in this group will be followed by a personalized diet and be followed up by a dietician.
Control Group: Diet Group
Patient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician.
Experimental: Oleuropein and Diet Group
Among those who applied to the clinic, those who want to follow their diet will be randomized into this group. Patients in this group will be followed by a personalized diet and will receive 2 capsules which100 grams of standardized oleuropein-containing olive leaf extract.
Control Group: Diet Group
Patient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician.
Oleuropein and Diet Group
Dietary Supplement: Oleuropein (Olive Leaf Extract) Patients in "Oleuropein and Diet Group" will receive 200 mg/day oleuropein supplement and personalized diet followed up by a dietician.
Interventions
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Control Group: Diet Group
Patient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician.
Oleuropein and Diet Group
Dietary Supplement: Oleuropein (Olive Leaf Extract) Patients in "Oleuropein and Diet Group" will receive 200 mg/day oleuropein supplement and personalized diet followed up by a dietician.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Metabolic Syndrome
* Individuals who did not have any infection at the time the study started
* Not consuming any medication
* Not pregnant or lactating
* Women aged 18-49 who have not entered menopause and men in the same age group
* Willing to consume the given extract
* Not allergic or intolerant to olive leaves
* No history of drug use
* People with a BMI below 40 kg/m2
Exclusion Criteria
* Any health issues that may affect the results of the research during the research.
* Occurrence of the problem and/or infection
* Becoming pregnant during the research
* Being in the experimental group and not consuming extract regularly
* Failure to comply with the regulated medical nutrition treatment
* Failure to participate in routine meetings and failure to complete necessary measurements
* Starting to use any medication or nutritional supplement during the study
* Leaving study voluntarily
18 Years
49 Years
ALL
No
Sponsors
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Atlas University
OTHER
Responsible Party
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Gulen Ecem Kalkan
Researcher
Principal Investigators
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Gülen Ecem Kalkan, PhD
Role: PRINCIPAL_INVESTIGATOR
Atlas University
Müveddet Emel Alphan, Prof
Role: STUDY_DIRECTOR
Atlas University
Locations
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Atlas University
Istanbul, Kağıthane, Turkey (Türkiye)
Countries
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Other Identifiers
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EcemMS
Identifier Type: -
Identifier Source: org_study_id
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