An interventional study of Control Group: Diet Group and Oleuropein and Diet Group in Metabolic Syndrome, Insulin Resistance and Obesity, Abdominal, sponsored by Atlas University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Atlas University · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 34 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Atlas University is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
Time frame: 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.
Time frame: 6 weeks
Plan to share: No
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