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

Atlas University

Status: Active, not recruiting

Conditions: Obesity, Abdominal; Insulin Resistance; Obesity; Metabolic Syndrome

Treatments: Dietary Supplement: Oleuropein and Diet Group; Behavioral: Control Group: Diet Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06673914

EcemMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Control Group: Diet Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control Group: Diet Group

Experimental: Oleuropein and Diet Group

Experimental group

Description:

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.

Treatment:

Behavioral: Control Group: Diet Group

Dietary Supplement: Oleuropein and Diet Group