Clinical trial NCT06673914: EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME
Official title: EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Insulin Resistance
Obesity, Abdominal
Obesity
Keywords: metabolic syndrome
oleuropein
medical nutrition therapy
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in the Fasting Blood Glucose (mg/dl) at 6 weeks
timeFrame: 6 weeks
measure: Change from Baseline in the Insulin (uU/mL) at 6 weeks
timeFrame: 6 weeks
measure: Change from Baseline in the Triglyceride (TG) (mg/dl), high density lipoprotein (HDL-C) (mg/dl), low density lipoprotein (LDL-C) (mg/dl), Total Cholesterol (mg/dl) at 6 weeks
timeFrame: 6 weeks
measure: Change from Baseline in the HOMA-IR at 6 weeks
timeFrame: 6 weeks
measure: Change from Baseline in the BMI (kg/m2)
timeFrame: 6 weeks
measure: Change from Baseline in the Anthropometric Measurements
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Atlas University
state: Kağıthane
Study officials:
affiliation: Atlas University
name: Gülen Ecem Kalkan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlas University
name: Müveddet Emel Alphan, Prof
role: STUDY_DIRECTOR
References: