Protocol summary
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Study aim
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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.
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Design
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This study will be done on sixty obese patients of both genders.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Expression of PPAR-γ, SIRT1, PGC-1α, and AMPK genes
General information
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Reason for update
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Adding secondary outcomes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090609002017N36
Registration date:
2023-03-19, 1401/12/28
Registration timing:
prospective
Last update:
2024-08-27, 1403/06/06
Update count:
1
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Registration date
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2023-03-19, 1401/12/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-25, 1402/09/04
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Expected recruitment end date
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2024-05-24, 1403/03/04
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Assessment of the effect of boron citrate supplementation in the prevention and treatment of obesity
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Ages between 18 to 60 years
body mass index (BMI) 30 to 40 kg/m2
Residence in Tabriz
Exclusion criteria:
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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-12-26, 1401/10/05
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Ethics committee reference number
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IR.TBZMED.REC.1401.881
Health conditions studied
1
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Description of health condition studied
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Obesity
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ICD-10 code
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E66.0
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ICD-10 code description
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Obesity due to excess calories
Primary outcomes
1
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Description
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PPAR-γ gene expression
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Timepoint
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The beginning and end of the study
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Method of measurement
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Measurement of gene expression by RT-PCR method
2
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Description
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SIRT1 gene expression
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Timepoint
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The beginning and end of the study
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Method of measurement
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Measurement of gene expression by RT-PCR method
3
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Description
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PGC-1α gene expression
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Timepoint
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The beginning and end of the study
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Method of measurement
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Measurement of gene expression by RT-PCR method
4
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Description
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AMPK gene expression
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Timepoint
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The beginning and end of the study
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Method of measurement
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Measurement of gene expression by RT-PCR method
Secondary outcomes
1
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Description
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Serum level of triiodothyronine (T3)
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Timepoint
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The beginning and end of the study
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Method of measurement
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ELISA
2
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Description
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Serum level of tetraiodothyronine (T4)
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Timepoint
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The beginning and end of the study
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Method of measurement
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ELISA
3
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Description
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Serum level of thyroid Stimulating hormone (TSH)
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Timepoint
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The beginning and end of the study
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Method of measurement
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ELISA
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data collected for the primary outcomes will be shared.
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When the data will become available and for how long
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Data will be available 12 months after manuscript publication
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To whom data/document is available
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The data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
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From where data/document is obtainable
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The researchers (student and her supervisor)
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What processes are involved for a request to access data/document
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Request a document via email
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Comments
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