Protocol summary
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Study aim
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The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, inflammatory indices, serum level of thyroid hormones and oxidative stress indices in obese people
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Design
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randomized, double-blinded, controlled trial, containing supplement and intervention groups, with parallel groups, sample size of 60 participants (30 in each group), RAS (Random Allocation Software) used for randomization.
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Settings and conduct
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This study will be conducted on 60 obese patients at Tabriz University of Medical Sciences Faculty of Nutrition. Patients will be divided into 2 equal groups of supplement and placebo and will receive boron citrate and placebo (maltodextrin) respectively for 12 weeks. In order to blind all researchers and participants, a person not involved in the experiment randomly assigns a list to the participants in each group and labels all identical containers (in appearance and color) according to their number. Therefore, participants will be unaware of the type of intervention they are receiving. The random sequence will also be unpredictable.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: obese people/Exclusion criteria: pregnancy and breastfeeding, smoking, following special diets 3 months before the study, taking chemical or herbal weight loss drugs, taking hepatotoxic drugs, taking blood pressure control drugs and blood lipid-lowering drugs
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Intervention groups
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Participants will be divided into two groups of 30 people: intervention group (1 capsule containing 10 mg boron citrate per day before lunch) and placebo group (1 capsule per day of maltodextrin before lunch) and will use the supplement or placebo for 12 weeks.
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Main outcome variables
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glucose-insulin-HbA1c-insulin resistance with HOMA-IR score, lipid pattern, systolic and diastolic blood pressure)
CRP, TNF-α, IL-10, and IL-6
General information
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Reason for update
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Delay in obtaining the necessary financial credit to start the project
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220806055624N1
Registration date:
2022-08-31, 1401/06/09
Registration timing:
prospective
Last update:
2024-08-29, 1403/06/08
Update count:
3
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Registration date
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2022-08-31, 1401/06/09
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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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2023-06-20, 1402/03/30
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Expected recruitment end date
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2023-12-21, 1402/09/30
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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 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
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Public title
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Boron citrate in obesity
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
BMI: 30–40 (kg/m²)
Willingness to participate in the study
Exclusion criteria:
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
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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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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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 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.
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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.
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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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2022-07-11, 1401/04/20
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Ethics committee reference number
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IR.TBZMED.REC.1401.350
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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Weight
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Weight scale
2
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Description
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Body mass index (BMI)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on formula
3
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Description
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Waist circumference (WC)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Tape measure
4
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Description
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Waist to hip ratio (WHR)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on formula
5
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Description
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Waist to height ratio (WHtR)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on formula
6
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Description
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C-reactive protein (CRP)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
7
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Description
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Tumor necrosis factor-α (TNF-α)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
8
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Description
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Interleukin-10 (IL-10)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
9
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Description
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Interleukin-6 (IL-6)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
10
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Description
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Hip circumference (HC)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Tape measure
Secondary outcomes
1
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Description
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Fasting blood sugar (FBS)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Use of an enzymatic kit method
2
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Description
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Fasting insulin levels
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
3
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Description
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Insulin resistance with HOMA-IR score
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on formula
4
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Description
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Low density lipoprotein cholesterol (LDL-c)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on the Friedewald formula
5
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Description
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High density lipoprotein cholesterol (HDL-c)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Use of an enzymatic kit method
6
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Description
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Total cholesterol (TC)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Use of an enzymatic kit method
7
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Description
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Triglyceride (TG)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Use of an enzymatic kit method
8
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Description
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Systolic blood pressure (SBP)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Mercury manometer
9
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Description
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Diastolic blood pressure (DBP)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Mercury manometer
10
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Description
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Quantitative insulin sensitivity check index (QUICKI)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Calculation based on formula
11
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Description
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Serum level of triiodothyronine (T3)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
12
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Description
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Serum level of tetraiodothyronine (T4)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
13
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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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Beginning and end of the trial
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Method of measurement
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ELISA
14
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Description
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Prooxidant - Antioxidant balance (PAB)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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ELISA
15
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Description
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Superoxide dismutase (SOD)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Spectrophotometric method and the Randox kit
16
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Description
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Glutathione Peroxidase (GPX)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Spectrophotometricmethod and the Randox kit
17
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Description
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Total antioxidant capacity (TAC)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Spectrophotometricmethod and the Randox kit
18
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Description
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Gene expression of CRP
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
19
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Description
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Gene expression of TNF-α
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
20
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Description
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Gene expression of IL-6
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
21
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Description
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Gene expression of IL-10
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
22
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Description
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Gene expression of AMPK
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
23
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Description
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Gene expression of PPAR-γ
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
24
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Description
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Gene expression of SIRT1
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
25
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Description
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Gene expression of PGC-1α
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Real-Time polymerase chain reaction (PCR) method
26
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Description
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Total body fat mass (FM)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Bioelectrical impedance analysis
27
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Description
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Total body fat free mass (FFM)
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Timepoint
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Beginning and end of the trial
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Method of measurement
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Bioelectrical impedance analysis
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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access starting 12 months after 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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