EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME

NCT ID: NCT06673914

Last Updated: 2024-11-05

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-01-15

Brief Summary

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The aim of this study is to determine the effect of 6 weeks supplementation of oleuropein on individuals diagnosed with metabolic syndrome. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.

Detailed Description

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This study was conducted to investigate the effect of adding oleuropein to the medical nutrition therapy of individuals with metabolic syndrome on their anthropometric measurements and biochemical parameters.

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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Metabolic Syndrome Insulin Resistance Obesity, Abdominal Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Control Group: Diet Group

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Control Group: Diet Group

Intervention Type BEHAVIORAL

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Individuals who volunteer to participate in the study by signing the voluntary consent form
* 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

* The patient included in the study leaves the study
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atlas University

OTHER

Sponsor Role lead

Responsible Party

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Gulen Ecem Kalkan

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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EcemMS

Identifier Type: -

Identifier Source: org_study_id

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