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

The current study will be conducted with the aim of investigating the effect of boron citrate supplementation on the thyroid hormones and expression of PPAR-γ, SIRT1, PGC-1α and AMPK genes in obese people.

This study will be done on sixty obese patients of both genders.

The study will be conducted in the Nutrition Research Center of Tabriz University of Medical Sciences and supplementation duration will be 12 weeks. The boron citrate and placebo packs will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of the supplements.

Inclusion criteria: Adults aged between 18-60 years and with a body-mass index of 30 to 40 kg/m2. Exclusion criteria: Individuals who are smokers, those consuming alcohol, 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 will not be included. We also will not include 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 will be excluded. Also, those who underwent weight loss surgery in the last year or weight loss diets in the last three months will not be included in the study.

Patients in the boron citrate group will take one capsule containing 10 mg of boron daily. In the placebo group, one capsule containing 10 mg of maltodextrin will be consumed daily.

Expression of PPAR-γ, SIRT1, PGC-1α, and AMPK genes

Adding secondary outcomes

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.

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.

Data collected for the primary outcomes will be shared.

Data will be available 12 months after manuscript publication

The data will only be available for people working in academic institutions.

The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.

The researchers (student and her supervisor)

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