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IRCT20090609002017N36 IRCT 2023-03-19 Tabriz University of Medical Sciences Assessment of the effect of boron citrate supplementation in the prevention and treatment of obesity The effect of boron citrate supplementation on the thyroid hormones and expression of PPAR-γ, SIRT1, PGC-1α, and AMPK genes in obese subjects: a double-blind randomized controlled clinical trial 2023-11-25 anticipated 30 Complete https://irct.ir/trial/69060 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 separation of groups until the end of the study and data analysis. 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 and data analyses. 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: Data will be available 12 months after manuscript 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 Dr. Alireza Ostadrahimi
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Alireza Ostadrahimi
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Ages between 18 to 60 years body mass index (BMI) 30 to 40 kg/m2 Residence in Tabriz 18 years 60 years Both Smokers Consuming alcohol Individuals taking chemical or herbal drugs for weight loss, hepatotoxic drugs, anti-hypertensive drugs, lipid-lowering and anti-diabetic drugs, corticosteroid, and non-steroidal anti-inflammatory drugs and antibiotics. Individuals who are pregnant, lactating, menopause, and those who use birth control pills and estrogen Individuals who have some pathologic conditions such as cardiovascular, liver, thyroid, parathyroid, kidney, gastrointestinal tract and autoimmune diseases as well as suffering from polycystic ovary syndrome, cancer and inflammatory disease Individuals who underwent weight loss surgery in the last year or weight loss diets in the last three months 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. PPAR-γ gene expression. Timepoint: The beginning and end of the study. Method of measurement: Measurement of gene expression by RT-PCR method. SIRT1 gene expression. Timepoint: The beginning and end of the study. Method of measurement: Measurement of gene expression by RT-PCR method. PGC-1α gene expression. Timepoint: The beginning and end of the study. Method of measurement: Measurement of gene expression by RT-PCR method. AMPK gene expression. Timepoint: The beginning and end of the study. Method of measurement: Measurement of gene expression by RT-PCR method. Serum level of triiodothyronine (T3). Timepoint: The beginning and end of the study. Method of measurement: ELISA. Serum level of tetraiodothyronine (T4). Timepoint: The beginning and end of the study. Method of measurement: ELISA. Serum level of thyroid Stimulating hormone (TSH). Timepoint: The beginning and end of the study. Method of measurement: ELISA. Tabriz University of Medical Sciences Approved 2022-12-26 Ethics Committee Tabriz University of Medical Sciences Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)