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

N/AActive Not RecruitingNCT06673914

Atlas University34 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metabolic Syndrome Insulin Resistance Obesity, Abdominal Obesity

Interventions

Control Group: Diet GroupBEHAVIORAL

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 GroupDIETARY_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

Atlas University

Istanbul, Kağıthane, Turkey (Türkiye)

Outcomes

Primary Outcomes

Change from Baseline in the Fasting Blood Glucose (mg/dl) at 6 weeks

The fasting blood glucose (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.

Time frame: 6 weeks

Change from Baseline in the Insulin (uU/mL) at 6 weeks

The fasting blood glucose (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.

Time frame: 6 weeks

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

Triglyceride (TG) (mg/dl), high density lipoprotein (HDL-C) (mg/dl), low density lipoprotein (LDL-C) (mg/dl), Total Cholesterol (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.

Time frame: 6 weeks

Change from Baseline in the HOMA-IR at 6 weeks

The fasting blood glucose (mg/dl) and fasting insulin (mU/L) values of the individuals with metabolic syndrome at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. HOMA-IR calculated with the formula (fasting glucose (mg/dl) x fasting insulin (mU/L)) / 405. These values recorded for all groups.

Time frame: 6 weeks

Change from Baseline in the BMI (kg/m2)

The body weight (kg) and height (m) of the individuals with metabolic syndrome were measured at the baseline and again after 6 weeks by the researcher, who noted the values in their files. The height of the patients was measured with a fixed height meter at 0.5 cm intervals, with shoes off. For body analysis, an 8-electrode bioelectrical impedance (BIA) device, Inbody 270, which performs segmental analysis, was used. Patients were asked to remove all metal items (rings, earrings, bracelets, watches, phones, etc.), any heavy clothing, shoes, and socks before stepping on the device. The device was set to -1.0 kg to account for the remaining clothes. From these measurements, body weight, body fat (kg), body fat percentage (%), body muscle (kg), and body water (kg) values were recorded. Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared.

Data from ClinicalTrials.gov

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