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Active, Not Recruiting

NCT Number: NCT06673914

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlas University

Istanbul, Kağıthane, 34413, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. Change from Baseline in the HOMA-IR at 6 weeks

    Time frame: 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.

  5. Change from Baseline in the BMI (kg/m2)

    Time frame: 6 weeks

    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. Change from Baseline in the Anthropometric Measurements

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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