The effect of boron citrate supplementation on the expression of PPAR-γ, SIRT1, PGC-1α, and AMPK genes in obese subjects: a double-blind randomized controlled clinical trial
The current double-blind randomized controlled clinical trial study will be conducted with the aim of investigating the effect of boron citrate supplementation on the expression of PPAR-γ, SIRT1, PGC-1α and AMPK genes in obese people.
Design
This study will be done on sixty obese patients of both genders.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Expression of PPAR-γ, SIRT1, PGC-1α, and AMPK genes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090609002017N36
Registration date:2023-03-19, 1401/12/28
Registration timing:prospective
Last update:2023-03-19, 1401/12/28
Update count:1
Registration date
2023-03-19, 1401/12/28
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-24, 1402/02/04
Expected recruitment end date
2023-10-26, 1402/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of boron citrate supplementation on the expression of PPAR-γ, SIRT1, PGC-1α, and AMPK genes in obese subjects: a double-blind randomized controlled clinical trial
Public title
Assessment of the effect of boron citrate supplementation in the prevention and treatment of obesity
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Tabriz University of Medical Sciences
Street address
Third Floor, Central Building (2), Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
00984133344280
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.TBZMED.REC.1401.881
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
PPAR-γ gene expression
Timepoint
The beginning and end of the study
Method of measurement
Measurement of gene expression by RT-PCR method
2
Description
SIRT1 gene expression
Timepoint
The beginning and end of the study
Method of measurement
Measurement of gene expression by RT-PCR method
3
Description
PGC-1α gene expression
Timepoint
The beginning and end of the study
Method of measurement
Measurement of gene expression by RT-PCR method
4
Description
AMPK gene expression
Timepoint
The beginning and end of the study
Method of measurement
Measurement of gene expression by RT-PCR method
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Research Center of Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Attar Neyshabouri Street, Golgasht Avenue, Nutrition faculty, Tabriz University of Medical Science, Ground Floor
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
ostadrahimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Ostadrahimi
Street address
Tabriz University of Medical Sciences, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
ostadrahimi@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
ostadrahimi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Assistant Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Data will be available 12 months after manuscript publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
The researchers (student and her supervisor)
What processes are involved for a request to access data/document