EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kağıthane
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Istanbul, Kağıthane, Turkey, 34413
- Atlas University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control Group: Diet Group
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.
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Patient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician.
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Experimental: Experimental: Oleuropein and 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 will receive 2 capsules which100 grams of standardized oleuropein-containing olive leaf extract.
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Patient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline in the Fasting Blood Glucose (mg/dl) at 6 weeks
Time Frame: 6 weeks
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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.
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6 weeks
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Change from Baseline in the Insulin (uU/mL) at 6 weeks
Time Frame: 6 weeks
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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.
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6 weeks
|
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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
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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.
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6 weeks
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Change from Baseline in the HOMA-IR at 6 weeks
Time Frame: 6 weeks
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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.
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6 weeks
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Change from Baseline in the BMI (kg/m2)
Time Frame: 6 weeks
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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
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Change from Baseline in the Anthropometric Measurements
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gülen Ecem Kalkan, PhD, Atlas University
- Study Director: Müveddet Emel Alphan, Prof, Atlas University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EcemMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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