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IRCT20140203016465N7 IRCT 2021-01-29 Tehran University of Medical Sciences The effect of superfood (NBS) on depression, anxiety, stress and weight Evaluating the effects of the supplement supper food (NBS) on depression, anxiety, stress and weight in women with depression and overweight (or obesity) compared to control group 2020-04-08 anticipated 50 Complete https://irct.ir/trial/51993 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Simple randomization using a computer randomization method, in this method we randomly place each client in the intervention or control group Randomization unit: individual Randomization tool and randomization sequence: determined by excel software and RAND Function How to hide allocation concealment: The type of treatment allocated in the two groups is completely unpredictable. Assignment to groups is also hidden from the researcher and patients by coding the NBS supplement and placebo groups, Blinding description: This clinical trial is planned so that the participant does not know which of the two groups of placebo or the main supplement belongs by coding the supplement and placebo. Also, the clinician, researcher, outcome evaluator, and data analyst do not have any information about the individuals in the placebo and main supplement groups. N/A Condition 1: Mild Depression. Condition 2: moderate depression. Condition 3: obesity. Intervention 1: Intervention group: daily, 5 grams of wheat germ powder supplement (produced by Super Food NBS). Intervention 2: Control group: 5 grams placebo of wheat germ powder (produced by Super Food NBS). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after individual identifications being removed When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The analyzes used in the article are allowed on the delivered data. Where to obtain: Requests for data/documentation should only be sent via email to the developer. Responsible person: Dr. Seyed Ali Mostafavi E-Mail: Mostafavi_a@sina.tums.ac.ir How to obtain: After receiving the email requesting documents or data files, this information will be sent to the requesting email as soon as possible. Comments:
public Seyed-Ali Mostafavi
Psychiatric Research Center, Roozbeh Hospital, South Kargar Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1333795914 +98 21 5542 1959 mostafavi_a@sina.tums.ac.ir Tehran University of Medical Sciences scientific Seyed-Ali Mostafavi
Psychiatric Research Center, Roozbeh Hospital, South Kargar Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1333795914 +98 21 5542 1959 mostafavi_a@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 50 years overweight or obesity diagnosis of depression based on DSM-5 criteria signing of the consent form 18 years 50 years Female People taking antidepressants. Also severe depression, psychotic depression or suicidal ideation Taking glucocorticoids and steroidal anti-inflammatory drugs People who take medicine to reduce appetite or weight People with diabetes who are taking medication or insulin People with heart disease or hypercholesterolemia who take drugs (stein, fibrates, diuretics) Contraceptive hormones Pregnancy and lactation Menopause Severe mental disorders, bipolar and schizophrenia and ... Hypothyroidism F32.0 F32.1 E66.0 Major depressive disorder, single episode, mild Major depressive disorder, single episode, moderate Obesity due to excess calories Other Placebo Intervention group: daily, 5 grams of wheat germ powder supplement (produced by Super Food NBS) Control group: 5 grams placebo of wheat germ powder (produced by Super Food NBS) Depression score in depression anxiety stress scale-21 (DASS-21) questionnaire. Timepoint: Baseline, week 4, and week 8. Method of measurement: depression anxiety stress scale-21 (DASS-21) questionnaire. Weight. Timepoint: Baseline, week 4, and week 8. Method of measurement: Standard scales. Anxiety scored by depression anxiety stress scale (DASS-21). Timepoint: at baseline, week 4, and week 8. Method of measurement: Depression anxiety stress scale (DASS-21). Stress score by depression anxiety stress scale (DASS-21). Timepoint: at baseline, week 4, and week 8. Method of measurement: Depression anxiety stress scale (DASS-21). NBS Company Psychiatry and Psychology Research Center NBS Company Approved 2019-12-12 Ethics Committee of Tehran University of Medical Sciences No. 1, Ghods Street, Keshavarz Avenue, Tehran. Iran Tehran Tehran Iran (Islamic Republic of)