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IRCT20110314006065N3 IRCT 2021-10-31 Development of Medical Research in Iran Anti-inflammatory diets & mental health The effects of anti-inflammatory diet alone or in combination with acupuncture on mental health, advanced glycation end products (AGEs), anthropometric indices and metabolic status in diabetic patients with depression: A randomized, controlled clinical trial 2021-10-24 anticipated 90 Complete https://irct.ir/trial/58919 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible volunteers will be randomly allocated (1:1:1) into one of the three following groups: (i) receiving an individualized anti-inflammatory diet with acupuncture therapy (n=30), (ii) receiving an individualized anti-inflammatory diet alone (iii) receiving common diet (control group) (n=30). It is notable that volunteers will be randomized and allocated in each group based on the severity of depression (mild, moderate), age, and sex. The randomization will be carried out using an online system (https://www.sealedenvelope.com/). Once the randomization has been made, each patient is given a code with that she/he will be identified throughout the study. The randomization number will be assigned in a consecutive way. Randomization will not be exposed to those conducting the study and will be provided in sealed opaque envelopes with successive numbers. The envelope will be opened after signing the informed consent form and complying with the eligibility criteria by the patients. N/A Type 2 diabetes mellitus. Intervention 1: An individualized anti-inflammatory diet with acupuncture therapy. All three groups will receive common treatment (medications, weight-loss diet in overweight and obese subjects, healthy dietary recommendations) throughout the study. dietary inflammatory index score in accordance to 24-h dietary recall and FFQ will be calculated. In general, considering pro- and anti- inflammatory food parameters and their food sources, participants’ characteristics, and an individualized anti-inflammatory diet will be prepared for both intervention groups. Our designed protocol for "Diabetic patients with Depression" emphasizes on treating different dimensions, etiologies, and symptoms of depression, and we will avoid those points which are proven to have blood sugar increasing effects. For instance, ST36 (ZuSanLi), ST25 (TianShu),etc, would not be punctured for diabetic patients. Intervention 2: َAn individualized anti-inflammatory diet alone. All three groups will receive common treatment (medications, weight-loss diet in overweight and obese subjects, healthy dietary recommendations) throughout the study. dietary inflammatory index score in accordance to 24-h dietary recall and FFQ will be calculated. In general, considering pro- and anti- inflammatory food parameters and their food sources, participants’ characteristics, and an individualized anti-inflammatory diet will be prepared for both intervention groups. Intervention 3: Common diet. All three groups will receive common treatment (medications, weight-loss diet in overweight and obese subjects, healthy dietary recommendations) throughout the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not clear release schedule.
public Nazli Namazi
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8863 1298 nazli.namazi@yahoo.com Tehran University of Medical Sciences scientific Nazli Namazi
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8863 1298 nazli.namazi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Suffering from type 2 diabetes mellitus for more than 6 months. taking oral anti-diabetic medications suffering from mild-to-moderate depression 20 years 75 years Both injection of insulin or liraglutide taking medicinal herbs or herbal medicine, antibiotics, antioxidant supplements (multivitamins & minerals, vitamin E, vitamin C, Zinc), suffering from severe depression, having chronic heart -vascular diseases, severe depression, chronic liver chronic liver and kidney disease, uncontrolled thyroid and any other diabetes complications leads to inflammatory and oxidative conditions, other types of diabetes taking psychiatry medications. Pregnancy and lactation E08 Diabetes mellitus due to underlying condition Treatment - Other Treatment - Other Treatment - Other An individualized anti-inflammatory diet with acupuncture therapy. All three groups will receive common treatment (medications, weight-loss diet in overweight and obese subjects, healthy dietary recommendations) throughout the study. dietary inflammatory index score in accordance to 24-h dietary recall and FFQ will be calculated. In general, considering pro- and anti- inflammatory food parameters and their food sources, participants’ characteristics, and an individualized anti-inflammatory diet will be prepared for both intervention groups. Our designed protocol for "Diabetic patients with Depression" emphasizes on treating different dimensions, etiologies, and symptoms of depression, and we will avoid those points which are proven to have blood sugar increasing effects. For instance, ST36 (ZuSanLi), ST25 (TianShu),etc, would not be punctured for diabetic patients. َAn individualized anti-inflammatory diet alone. All three groups will receive common treatment (medications, weight-loss diet in overweight and obese subjects, healthy dietary recommendations) throughout the study. dietary inflammatory index score in accordance to 24-h dietary recall and FFQ will be calculated. In general, considering pro- and anti- inflammatory food parameters and their food sources, participants’ characteristics, and an individualized anti-inflammatory diet will be prepared for both intervention groups. Common diet. All three groups will receive common treatment (medications, weight-loss diet in overweight and obese subjects, healthy dietary recommendations) throughout the study. Depression. Timepoint: Baseline, after 8 weeks of the intervention (At the end of the intervention). Method of measurement: Montgomery-Asberg Depression Rating Scale (MADRS). Fat mass. Timepoint: Baseline, after 4 weeks of intervention and At the end of the intervention. Method of measurement: Bio-Electrical Impedance Analysis. Fat free mass. Timepoint: Baseline, after 4 weeks of intervention and At the end of the intervention. Method of measurement: Bio-Electrical Impedance Analysis. HbA1c. Timepoint: Baseline, At the end of the intervention. Method of measurement: Chromatography. Advanced glycation end products. Timepoint: Baseline, At the end of the intervention. Method of measurement: ELISA kit. FBS. Timepoint: Baseline, At the end of the intervention. Method of measurement: Autoanalyzer. Total cholesterol. Timepoint: Baseline, At the end of the intervention. Method of measurement: Autoanalyzer. Low-density lipoprotein. Timepoint: Baseline, At the end of the intervention. Method of measurement: Autoanalyzer. High-density lipoprotein. Timepoint: Baseline, At the end of the intervention. Method of measurement: Autoanalyzer. High-sensitivity C-reactive protein. Timepoint: Baseline, At the end of the intervention. Method of measurement: ELISA kit. Development of Medical Research in Iran Approved 2019-12-07 National Institute for Medical Research Development Iran National Institute for Development of Medical Research (NIMAD), No. 21, beginning of Besat St., West Fatemi St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)