Obesity. Overweight and obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adolescents aged 12-18 with obesity (BMI-for-age = 95th percentile) Written informed consent from both participants and their legal guardians. Participants capable of full compliance with the study protocol and able to attend scheduled visits. Participants who have experienced a maximum of 5% body weight changes in the last three months.
Exclusion criteria
Exclusion criteria: Adolescents with a history of hypo- or hyperthyroidism, renal failure, routine coffee consumption, and taking corticosteroids Adolescents with a history of gastrointestinal disorders that may affect nutrient absorption (e.g., inflammatory bowel disease, celiac disease) History of significant medical conditions or medications that may impact body composition or metabolic markers Participation in any concurrent weight management or dietary intervention program Female adolescents who are pregnant, lactating, or planning pregnancy during the study period Sensitivity to green coffee bean extract or its components Undergoing any surgical procedure in the past year that may impact metabolism and body weight Significant psychiatric disorders affecting the patient's medication compliance Routine coffee consumption of two or more cups per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMI z-score. Timepoint: The change in BMI z-score from baseline (before starting the intervention) to 8 weeks after intervention. Method of measurement: Calculation of BMI by weight and height of the person (kilograms per square of height) and calculation of z score using the mean and standard deviation of the variable in the target population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in anthropometric indices. Timepoint: Changes in anthropometric indices from baseline to 8 weeks after intervention. Method of measurement: Height: Measured using a stadiometer, with the participant standing barefoot, heels together, and head in the Frankfort horizontal plane. Weight: Measured using a calibrated digital scale with the participant in light clothing. Waist Circumference: Measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Hip Circumference: Measured around the widest portion of the buttocks, with the tape parallel to the floor. Waist-to-Hip Ratio: Calculated by dividing waist circumference by hip circumference.;Metabolic profiles, including lipid profile, glucose metabolism markers, and insulin levels. Timepoint: Metabolic profiles, including lipid profile, glucose metabolism markers, insulin levels, and inflammatory markers from baseline to 8 weeks after intervention. Method of measurement: Glucose Metabolism: Fasting blood samples will be collected after an overnight fast. Blood glucose levels will be measured using standard laboratory techniques (e.g., enzymatic methods, glucose oxidase assays). Lipid Profile: Fasting blood samples will be collected after an overnight fast. Lipid levels, including total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides, will be assessed using standard laboratory methods. Inflammatory Markers (e.g., CRP): Fasting blood samples will be collected after an overnight fast. Levels of inflammatory markers will be quantified using enzyme-linked immunosorbent assay (ELISA) techniques, which involve specific antibodies for each marker. Insulin levels: Fasting blood samples, obtained after an overnight fast, will be analyzed to determine insulin levels. The measurement will employ standard laboratory methods, likely utilizing immunoassay techniques to quantify the concentration of insulin in the blood. | — |
Countries
Iran (Islamic Republic of)
Contacts
Esfahan University of Medical Sciences