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IRCT20150205020965N10 IRCT 2021-12-11 Tabriz University of Medical Sciences The effect of date seed powder on diabetes The effect of date seed powder supplementation on nutritional status, metabolic, oxidative stress and inflammatory parameters in diabetes type 2 patients 2022-04-09 anticipated 42 Complete https://irct.ir/trial/58044 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: At baseline, eligible individuals will be matched for BMI and age according to the classification of these variables. Individuals will be randomly divided into two groups, the intervention group (n=21, receiving date seed powder) control (n=21, receiving Maltodextrin) using RAS software into 2 and 4 blocks, and will be given codes 1 and 2, Blinding description: After randomization, both groups will be given date seed powder and maltodextrin that encoded in sachets weighing 2.5 g in similar packages (metalized) without the researcher intervention and coded with codes 1 and 2. Until releasing of study results, the patient, the researcher, and the data analyzer will not be aware of the assigned codes. Therefore, the study will be three-blind. N/A Type 2 diabetes. Intervention 1: Intervention group: date seed powder. This group will consume two sachets of 2.5 g of date seed powder (Flavinea Company, Iran) daily for 2 months in the morning and evening in food such as drinks or yogurt. Intervention 2: Control group: maltodextrin. The group will consume two sachets of 2.5 g of maltodextrin (Qinhuangdao Lihua Starch co, china) daily for two months in the morning and evening in foods such as beverages or yogurt. Yes - There is a plan to make this available What will be shared: Participant data will be presented in the article without identifiable details When: 2022-2023 To whom: Tabriz University of Medical Sciences Conditions: The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed. Where to obtain: Tabriz University of Medical Sciences How to obtain: The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed. Comments:
public Parvin Dehghan
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7581 dehghan.nut@gmail.com Tabriz University of Medical Sciences scientific Parvin Dehghan
Attar Neyshabori Street, Golghash street, Nutrition Faculty, Tabriz University Of Medical Sciences,
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 dehghanp@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Have at least 6 months of diabetes history No weight changes during the last 3 months No insulin therapy Use of blood sugar lowering drugs Tendency to consume palm kernel powder during the study Having a BMI between 25 and 35 30 years 50 years Both Use of glucocorticoids, laxatives, anti-obesity, multivitamins, nonsteroidal anti-inflammatory drugs (NSAIDS) and antibiotics Take antioxidant supplements at least three months before the start of the study History of weight loss diet in the last 6 months or special diet Having diseases such as intestinal diseases such as inflammation of the intestines, intestinal cancer and digestive problems Having thyroid disorders, heart disease, kidney, liver, lung, infectious and other cancers treated with radiotherapy Alcohol or smoking Pregnancy, breastfeeding, being an athlete or doing strenuous physical activity E11 Type 2 diabetes mellitus Treatment - Other Placebo Intervention group: date seed powder. This group will consume two sachets of 2.5 g of date seed powder (Flavinea Company, Iran) daily for 2 months in the morning and evening in food such as drinks or yogurt. Control group: maltodextrin. The group will consume two sachets of 2.5 g of maltodextrin (Qinhuangdao Lihua Starch co, china) daily for two months in the morning and evening in foods such as beverages or yogurt. Lipid profile (TG, TC, HDL-c). Timepoint: At baseline and and two months after the start of the study. Method of measurement: Kit. Total antioxidant capacity. Timepoint: At baseline and two months after start of the study. Method of measurement: Kit. Malondialdehyde. Timepoint: At baseline and two months after start of the study. Method of measurement: kit. Tumor Necrosis Factor(TNF). Timepoint: At baseline and two months after start of the study. Method of measurement: kit. Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and two months after start of the study. Method of measurement: kit. HbA1c. Timepoint: At baseline and two months after start of the study. Method of measurement: kit. Fasting glucose. Timepoint: At baseline and two months after start of the study. Method of measurement: kit. Fasting insulin. Timepoint: At baseline and two months after start of the study. Method of measurement: kit. Interleukins 4, 6, 10, 18. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Fructosamine. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. LPS endotoxin. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Pentosidine. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Total oxidant status (TOS). Timepoint: At baseline and two months after start of the study. Method of measurement: kit. Carboxymethyl lysine (CML). Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Soluble receptor for advanced glycation end-products. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. 8-iso-prostaglandin F2α. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Brain-derived neurotrophic factor. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Cortisol. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Tryptophan. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Kynurenine. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Adrenocorticotropic hormone. Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. Adipokines (leptin and adiponectin). Timepoint: At baseline and two months after start of the study. Method of measurement: enzyme-linked immunosorbent assay (ELISA) kit. T lymphocyte ( CD4 and CD8). Timepoint: At baseline and two months after start of the study. Method of measurement: flow cytometry. Glutathione peroxidase. Timepoint: At baseline and two months after start of the study. Method of measurement: Kit. Superoxide dismutase. Timepoint: At baseline and two months after start of the study. Method of measurement: Kit. Catalase. Timepoint: At baseline and two months after start of the study. Method of measurement: Kit. Uric acid. Timepoint: At baseline and two months after start of the study. Method of measurement: kit. 8-Hydroxy-2-deoxy-guanosine. Timepoint: At baseline and two months after start of the study. Method of measurement: kit. Body Mass Index (BMI). Timepoint: At baseline and two months after baseline. Method of measurement: Scale-Meter. Energy intake, Daily macronutrient intake (carbohydrate, protein, fat). Timepoint: At baseline and two months after baseline. Method of measurement: questionnaire. General Health , Sleep quality, Depression, Anxiety and Stress. Timepoint: At baseline and two months after baseline. Method of measurement: questionnaire. Blood pressure. Timepoint: At baseline and two months after baseline. Method of measurement: manometer. Tabriz University of Medical Sciences Approved 2020-10-16 Ethics committee of Tabriz University of Medical Sciences Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. Tabriz East Azarbaijan Iran (Islamic Republic of)