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IRCT20150205020965N7 IRCT 2020-12-23 Tabriz University of Medical Sciences The effect of bitter almond gum supplement on type 2 diabetes The effect of bitter almond gum supplement on the metabolic, inflammatory, and mental health indicators in women with type 2 diabetes 2020-11-21 anticipated 44 Complete https://irct.ir/trial/51883 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be divided into two groups using balanced block randomization: 1) bitter almond gum consumer 2) placebo consumer. First, the quadruple Blocks and arrangement of blocks with their numbering will be determined. Then after the selection of specific blocks using a random number table and based on the number of blocks, entering the first four participants will be done. Then again, determination of the next block will be done using the random number table and this will continue until we reach the specified sample size, Blinding description: Bitter almond gum and maltodextrin (Both have the same taste, color, and smell) were delivered to patients monthly in similar cellophanes and unrecognizable without mentioning the type of supplement on the packages. In order to separate the two types of powders, in the factory, using a digital device, the code and date of production and expiration will be printed on the packages. In order for the researcher to be unaware of the patient's treatment, distribution of supplements, and placebo by another person Codes and type of supplement not known will be done. Until the study results are released, the patient, researcher, and data analyzer will not know the assigned codes. 3 Type 2 diabetes. Intervention 1: Intervention group: Bitter almond gum. This group will dissolve and consume two sachets (2* 5 gr) of Bitter almond gum ( Payar Tejarat Zomorodin Company, Iran) twice a day, in the morning and in the evening, in lukewarm water for 2 months. Intervention 2: Control group: maltodextrin. This group will dissolve and consume two sachets ( 2*5 gr) of maltodextrin (Qinhuangdao Lihua Starch co, china) twice a day, in the morning and in the evening, in lukewarm water for 2 months. 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: 2020-2021 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
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 33340634 dehghan.nut@gmail.com Tabriz University of Medical Sciences scientific Parvin Dehghan
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 33340634 dehghan.nut@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Having type 2 diabetes for more than six months according to International Diabetes Federation (fasting blood sugar level more than 126 mg/dl) Age: 30-50 y Using anti-diabetic drugs and maintaining them in the period of the study Having a normal diet Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months 30 years 50 years Female Having a history of gastrointestinal Having history cardiovascular Having a history of renal Having a history of thyroid Having a history of liver; or pancreatic diseases Pregnancy and lactating Smokers Consuming prebiotic and probiotics’ products E 11 Type 2 diabetes mellitus Treatment - Other Placebo Intervention group: Bitter almond gum. This group will dissolve and consume two sachets (2* 5 gr) of Bitter almond gum ( Payar Tejarat Zomorodin Company, Iran) twice a day, in the morning and in the evening, in lukewarm water for 2 months. Control group: maltodextrin. This group will dissolve and consume two sachets ( 2*5 gr) of maltodextrin (Qinhuangdao Lihua Starch co, china) twice a day, in the morning and in the evening, in lukewarm water for 2 months. Hemoglobin A1C (HbA1c). Timepoint: At baseline and two months after baseline. Method of measurement: Autoanalyzer. Lipid profile (TG, TC, HDL-c). Timepoint: At baseline and two months after baseline. Method of measurement: Autoanalyzer. Tryptophan. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Kynurenine. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Fasting glucose. Timepoint: At baseline and two months after baseline. Method of measurement: Colorimetric Assay Kit. Cortisol. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza Kit. Glucagon-like peptide1. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Fasting insulin. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Carboxymethyl lysine. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. S-RAGE (soluble receptor for AGE). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Nitric oxide. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Interleukin 6. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Highly sensitive C-reactive protein(hs-CRP ). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Tumor Necrosis Factor (TNF). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Interleukin 10 (IL10 ). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Total antioxidant capacity. Timepoint: At baseline and two months after baseline. Method of measurement: Total Antioxidant Capacity (TAC) Assay Kit. Malondialdehyde. Timepoint: At baseline and two months after baseline. Method of measurement: Colorimetric Assay Kit. 8-iso-prostaglandin F2α (8-iso-PGF2α). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Leptin. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Adiponectin. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Ghrelin. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. PPAR-α expression. Timepoint: At baseline and two months after baseline. Method of measurement: Polymerase chain reaction (PCR). Lipopolysaccharide. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Interleukin 17. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. CD 8 lymphocyte. Timepoint: At baseline and two months after baseline. Method of measurement: Fucitometry. Interleukin 1. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. CD 4 lymphocyte. Timepoint: At baseline and two months after baseline. Method of measurement: Fucitometry. Brain-derived Neurotrophic Factor. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Vascular cell adhesion molecule cell (VCAM). Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Plasminogen activator inhibitor (PAI)-1. Timepoint: At baseline and two months after baseline. Method of measurement: Eliza kit. Body Mass Index (BMI). Timepoint: At baseline and two months after baseline. Method of measurement: Scale-Meter. Daily macronutrient intake (Energy, carbohydrate, protein, fat). Timepoint: At baseline and two months after baseline. Method of measurement: Questionnaire (24-hour Dietary Recall). Waist circumference (WHR). Timepoint: At baseline and two months after baseline. Method of measurement: Calculation. Blood pressure. Timepoint: At baseline and two months after baseline. Method of measurement: Mercuric barometr. Assessment of the body composition. Timepoint: At baseline and two months after baseline. Method of measurement: Bioelectrical impedance analysis. Mental health. Timepoint: At baseline and two months after baseline. Method of measurement: Questionnaire (Depression Anxiety Stress Questionnaire, General Health Questionnaire ). Appetite status. Timepoint: At baseline and two months after baseline. Method of measurement: Visual Analogue Scale Questionnaire. Tabriz University of Medical Sciences Approved 2020-10-17 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)