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

NCT06673914 | Active Not Recruiting

• 1 other identifier: EcemMS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal; Obesity

Keywords

metabolic syndrome; oleuropein; medical nutrition therapy

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  6 weeks

• Change from Baseline in the Anthropometric Measurements

  The anthropometric measurements of the individuals with metabolic syndrome at the baseline and 6 weeks taken by the researcher and noted in their files. These measurements included waist circumference (cm), hip circumference (cm), mid-upper arm circumference (cm), waist-to-height ratio (cm), and waist-to-hip ratio (cm). Waist circumference was measured using an inflexible tape at the umbilicus level after normal exhalation to the nearest 0.1 cm. Hip circumference was measured from the widest area between the waist and the thigh. The waist-to-hip ratio was calculated using the formula waist (cm)/hip (cm), and the waist-to-height ratio was calculated using the formula waist (cm)/height (cm). Mid-upper arm circumference was measured on the left arm of the patients. Neck circumference was measured with the shoulders in a free position from the point where the thyroid cartilage was most protruding.

  6 weeks

Study Arms (2)

Control Group: Diet Group

ACTIVE COMPARATOR

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.

Behavioral: Control Group: Diet Group

Experimental: Oleuropein and Diet Group

EXPERIMENTAL

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.

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

Interventions

Control Group: Diet Group BEHAVIORAL

Patient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician.

Control Group: Diet Group; Experimental: Oleuropein and Diet Group

Oleuropein and Diet Group 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.

Experimental: Oleuropein and Diet Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Atlas University

Istanbul, Kağıthane, 34413, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal; Obesity

Interventions

oleuropein

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülen Ecem Kalkan, PhD

  Atlas University

  PRINCIPAL INVESTIGATOR

• Müveddet Emel Alphan, Prof

  Atlas University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 15, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)