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IRCT20240213060993N1 IRCT 2024-02-18 Esfahan University of Medical Sciences effect of green coffee on obesity Effects of Green Bean Coffee Extract on Anthropometric indices, Body composition, and cardiometabolic risk factors in Obese Adolescents: A double blind, placebo controlled, Randomized Clinical Trial 2024-03-02 anticipated 70 Complete https://irct.ir/trial/75561 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total 70 participants will randomly be divided into two groups. Random allocation will be carried out using permuted block randomization method with size of 2, 4 and 6 stratified by sex. The random sequences will be generated by “blockrand” package in R. The capsules (placebo/trial medication) will be allocated to participants via coded medicine containers of identical appearance prepared by an independent pharmacy, Blinding description: To ensure double-blinding, neither the participants nor the research staff involved in the study will be aware of the treatment assignments. The envelopes will be opened by an independent third party, not involved in the study, who will administer the assigned treatment accordingly. Blinding will be implemented for trial participants, care providers, and outcome assessors. 3 Obesity. Intervention 1: Intervention group: Participants in the intervention group will receive green bean coffee extract containing 500 mg/day chlorogenic acid for 8 weeks. Intervention 2: Control group: Participants allocated to the control group will be administered a placebo composed of starch. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts 3 months after the results are published To whom: For researchers working in academic and scientific institutions Conditions: For include in systematic IPD studies Where to obtain: Corresponding author in the published study How to obtain: Within two weeks of correspondence by email Comments:
public Milad Maghsoudi
Sepahan Alley, Mobarizan St., Bozormehr St.
Isfahan Iran (Islamic Republic of) 8156615481 +98 31 3225 3817 miladmaghsoudi1996@gmail.com Esfahan University of Medical Sciences scientific Milad Maghsoudi
Sepahan Alley, Mobarizan St., Bozormehr St.
Isfahan Iran (Islamic Republic of) 8156615481 +98 31 3225 3817 miladmaghsoudi1996@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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. 12 years 18 years Both 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 E66 Overweight and obesity Treatment - Drugs Placebo Intervention group: Participants in the intervention group will receive green bean coffee extract containing 500 mg/day chlorogenic acid for 8 weeks Control group: Participants allocated to the control group will be administered a placebo composed of starch 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. 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. Esfahan University of Medical Sciences Approved 2023-12-27 Ethics committee of Isfahan University of Medical Sciences Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences, Hazar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)