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IRCT20220806055624N1 IRCT 2022-08-31 Tabriz University of Medical Sciences Boron citrate in obesity The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP and serum level of thyroid hormones and oxidative stress indices of SOD, PAB, GPx, TAC and gene expression of TNF-α, IL-10, IL-6, CRP, PPAR-γ، SIRT1، PGC-1α و AMPK in obese people 2023-06-20 anticipated 60 Complete https://irct.ir/trial/65202 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To stratify individuals into distinct strata and blocks, stratified block randomization will be implemented based on age (18-40 vs. 40-60 years) and gender (male vs. female). For each individual placed in a given stratum, a matched individual is considered based on these variables in the same stratum. As a result, two participants with similar characteristics (for age and gender) are placed in the same stratum. Finally, each stratum will be randomly allocated to the intervention or control groups using Random Allocation Software (RAS). Participants and researchers will be blinded to the randomization and allocation until the end of the study. The randomization list will be provided by the pharmacist of the research center at the end of the study, Blinding description: In this study, patients and researchers will be blind to the type of supplements (boron citrate or placebo). The person responsible for preparing the supplement packages (a person completely unrelated to the study) will be asked to assign a three-digit code to each of the two received supplements (boron citrate or placebo) and keep the codes for himself until the end of the study. N/A obesity. Intervention 1: Intervention group: Patients in this group will receive dietary recommendations and boron citrate capsules including 10 mg boron for 12 weeks. Boron citrate capsules is made in Iran, and once a day before lunch will be consumed. Intervention 2: Control group: Patients in this group will receive dietary recommendations with placebo for 12 weeks. The placebo is starch (containing 10 mg of maltodextrin) and once a day before lunch will be consumed. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: access starting 12 months after publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta-analysis. Where to obtain: The researchers (student and her supervisor) How to obtain: Request a document via email Comments:
public Helda Tutunchi
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 helda.nutrition@gmail.com Tabriz University of Medical Sciences scientific Helda Tutunchi
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 helda.nutrition@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) BMI: 30–40 (kg/m²) Willingness to participate in the study 18 years 60 years Both Athlete, pregnancy, lactation and menopause in women Under infertility treatment, taking birth control pills and estrogen Smoking and history of alcohol consumption Following a special diet three months before the study Use of chemical or herbal drugs for weight loss and use of hepatotoxic drugs such as phenytoin, amoxifene, lithium, blood pressure control drugs and blood lipid lowering drugs (statins), drugs that increase insulin sensitivity. Taking antibiotics or supplements affecting liver enzyme levels Weight loss surgery in the last year or strict weight loss diets in the last three months Using corticosteroid and non-steroidal anti-inflammatory drugs and any supplements for 3 months before the study or during the study Cardiovascular diseases, liver, kidney, intestinal, thyroid and parathyroid dysfunction, biliary disease, known autoimmune diseases, polycystic ovary syndrome, cancers and malabsorption diseases such as sprue and Crohn's Having symptoms of infectious or inflammatory disease or recent surgery Performed or candidate for liver transplant E66.0 Obesity due to excess calories Prevention Prevention Intervention group: Patients in this group will receive dietary recommendations and boron citrate capsules including 10 mg boron for 12 weeks. Boron citrate capsules is made in Iran, and once a day before lunch will be consumed. Control group: Patients in this group will receive dietary recommendations with placebo for 12 weeks. The placebo is starch (containing 10 mg of maltodextrin) and once a day before lunch will be consumed. Weight. Timepoint: Beginning and end of the trial. Method of measurement: Weight scale. Body mass index (BMI). Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula. Waist circumference (WC). Timepoint: Beginning and end of the trial. Method of measurement: Tape measure. Waist to hip ratio (WHR). Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula. Waist to height ratio (WHtR). Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula. C-reactive protein (CRP). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Tumor necrosis factor-α (TNF-α). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Interleukin-10 (IL-10). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Interleukin-6 (IL-6). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Hip circumference (HC). Timepoint: Beginning and end of the trial. Method of measurement: Tape measure. Fasting blood sugar (FBS). Timepoint: Beginning and end of the trial. Method of measurement: Use of an enzymatic kit method. Fasting insulin levels. Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Insulin resistance with HOMA-IR score. Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula. Low density lipoprotein cholesterol (LDL-c). Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on the Friedewald formula. High density lipoprotein cholesterol (HDL-c). Timepoint: Beginning and end of the trial. Method of measurement: Use of an enzymatic kit method. Total cholesterol (TC). Timepoint: Beginning and end of the trial. Method of measurement: Use of an enzymatic kit method. Triglyceride (TG). Timepoint: Beginning and end of the trial. Method of measurement: Use of an enzymatic kit method. Systolic blood pressure (SBP). Timepoint: Beginning and end of the trial. Method of measurement: Mercury manometer. Diastolic blood pressure (DBP). Timepoint: Beginning and end of the trial. Method of measurement: Mercury manometer. Quantitative insulin sensitivity check index (QUICKI). Timepoint: Beginning and end of the trial. Method of measurement: Calculation based on formula. Serum level of triiodothyronine (T3). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Serum level of tetraiodothyronine (T4). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Serum level of thyroid Stimulating hormone (TSH). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Prooxidant - Antioxidant balance (PAB). Timepoint: Beginning and end of the trial. Method of measurement: ELISA. Superoxide dismutase (SOD). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometric method and the Randox kit. Glutathione Peroxidase (GPX). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometricmethod and the Randox kit. Total antioxidant capacity (TAC). Timepoint: Beginning and end of the trial. Method of measurement: Spectrophotometricmethod and the Randox kit. Gene expression of CRP. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Gene expression of TNF-α. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Gene expression of IL-6. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Gene expression of IL-10. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Gene expression of AMPK. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Gene expression of PPAR-γ. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Gene expression of SIRT1. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Gene expression of PGC-1α. Timepoint: Beginning and end of the trial. Method of measurement: Real-Time polymerase chain reaction (PCR) method. Total body fat mass (FM). Timepoint: Beginning and end of the trial. Method of measurement: Bioelectrical impedance analysis. Total body fat free mass (FFM). Timepoint: Beginning and end of the trial. Method of measurement: Bioelectrical impedance analysis. Tabriz University of Medical Sciences Approved 2022-07-11 The specialized committee of ethics in biomedical research Daneshgah street Tabriz East Azarbaijan Iran (Islamic Republic of)