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IRCT20090203001640N18 IRCT 2020-06-14 Vice Chancellor for Research of Beheshti University of Medical Sciences Effect of green coffee extract supplementation in patients with type 2 diabetes Effect of green coffee extract supplementation on glycemic control, insulin resistance, lipid profile, advanced glycation end products, inflammatory and oxidant status in overweight/obese patients with type 2 diabetes : a randomized double-blind clinical trial 2020-09-15 anticipated 44 Complete https://irct.ir/trial/48549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups Participants were randomly assigned to intervention or control group in the random blocks based on the random number table.The sequence of permuted blocks was generated with a random number table. An individual with no clinical involvement in the trial, put the lable of intervention or control group in an opaque and sealed envelope based on the random sequence. Then the other person, who was not aware of random sequences and the envelope content, assigned the patients to the intervention or control group, Blinding description: This study is designed as a double blind study. The subjects, main investigator and outcome assessor are not aware of each patient's treatment assignment and the main investigator is not involved in the randomization process. N/A Type 2 diabetes. Intervention 1: Intervention group: Received 400 mg green coffee supplement two times a day orally for two months. Intervention 2: Control group: Placebo group: Received 400 mg starch capsule two times a day for two months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Parvin Mirmiran
No. 7, Shahid Hafezi Ave, Shahid frahzadi Blv, Tehran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2235 7483 parvin.mirmiran@gmail.com Shahid Beheshti University of Medical Sciences scientific Parvin mirmiran
No. 7, Shahid Hafezi Ave, Shahid frahzadi Blv, Tehran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2235 7483 parvin.mirmiran@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Agreement to participate in the study and completing informed consent form Subjects aged 35-70 years old Body mass index between 25-35 kg/m2 Fasting blood glucose ≥ 126 mg/dl or 2-h plasma glucose ≥200 mg/dl or treatment with anti-hyperglycemic medications 35 years 70 years Both Following any specific diet in past three months Pregnant and lactating women Insulin treatment E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Intervention group: Received 400 mg green coffee supplement two times a day orally for two months Control group: Placebo group: Received 400 mg starch capsule two times a day for two months Fasting blood glucose. Timepoint: At the beginning and end of the study. Method of measurement: Enzymatic /kit. Plasma insulin. Timepoint: At the beginning and end of the study. Method of measurement: ELISA. Plasma triglyceride. Timepoint: At the beginning and end of the study. Method of measurement: Enzymatic /kit. Malondialdehyde. Timepoint: At the beginning and end of the study. Method of measurement: Colorimetric. Carboxymethyl lysine. Timepoint: At the beginning and end of the study. Method of measurement: ELISA. High-sensitivity C-reactive protein. Timepoint: At the beginning and end of the study. Method of measurement: ELISA. Body mass index. Timepoint: At the beginning and end of the study. Method of measurement: Weight in kilograms divided by height in meters squared. Systolic blood pressure. Timepoint: At the beginning and end of the study. Method of measurement: Mercury sphygmomanometer. Diastolic blood pressure. Timepoint: At the beginning and end of the study. Method of measurement: Mercury sphygmomanometer. Vice Chancellor for Research of Beheshti University of Medical Sciences Approved 2020-05-13 national nutrition and food technology research institute No. 7, Shahid Hafezi Ave, Shahid frahzadi Blv, Tehran Tehra Tehran Iran (Islamic Republic of)