The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP in obese people
The effect of boron citrate supplementation on nutritional status, cardiometabolic factors and indices of TNF-α, IL-10, IL-6 and CRP in obese subjects.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220806055624N1
Registration date:2022-08-31, 1401/06/09
Registration timing:registered_while_recruiting
Last update:2022-08-31, 1401/06/09
Update count:3
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Helda Tutunchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
helda.nutrition@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP in obese people
Public title
Boron citrate in obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30=<BMI=<40
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified permuted block randomization will be applied to stratify participants into different stratum and blocks based on gender and probable confounders including age and BMI. Each block will be randomly allocated to the intervention or control groups. The sequence of the blocks will be prepared for each stratum Random Allocation Software (RAS). For each patient in a definite block, a matched person in terms of the aforementioned variables would be considered in that block. Participants and investigators will be blind to the trial group assignments until the end of the study and data analysis.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind all the investigators and participants, an individual not involved in the trial will make a randomized list assignment for the participants in each group and will label all the identical containers (in appearance and color) based on their numbers. Therefore, the participants will be unaware of the type of intervention they receive. The random sequence will be unpredictable, as well.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The specialized committee of ethics in biomedical research
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2022-07-11, 1401/04/20
Ethics committee reference number
IR.TBZMED.REC.1401.350
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
energy consumption
Timepoint
Beginning and end of the trial
Method of measurement
questionnaire
2
Description
macronutrient consumption
Timepoint
Beginning and end of the trial
Method of measurement
questionnaire
3
Description
weight
Timepoint
Beginning and end of the trial
Method of measurement
weight scale
4
Description
body mass scale
Timepoint
Beginning and end of the trial
Method of measurement
weight scale and stadiometer
5
Description
waist circumstance
Timepoint
Beginning and end of the trial
Method of measurement
tape measure
6
Description
waist to hio ratio
Timepoint
Beginning and end of the trial
Method of measurement
tape measure
7
Description
waist circumstance to height ratio
Timepoint
Beginning and end of the trial
Method of measurement
tape measure and stadiometer
8
Description
blood glucose
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
9
Description
Insulin
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
10
Description
HbA1C
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
11
Description
Insulin resistance with HOMA-IR score
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
12
Description
LDL-c
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
13
Description
HDL-c
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
14
Description
total cholesterol
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
15
Description
triglicerid
Timepoint
Beginning and end of the trial
Method of measurement
ELISA
16
Description
systolic blood pressure
Timepoint
Beginning and end of the trial
Method of measurement
mercury manometer
17
Description
diastolic blood pressure
Timepoint
Beginning and end of the trial
Method of measurement
mercury manometer
18
Description
CRP (c-reactive protein)
Timepoint
Beginning and end of the trial
Method of measurement
Elisa
19
Description
TNF-α (Tumor necrosis factor-α)
Timepoint
Beginning and end of the trial
Method of measurement
gene expression measurement with RT-PCR method
20
Description
IL-10
Timepoint
Beginning and end of the trial
Method of measurement
gene expression measurement with RT-PCR method
21
Description
IL-6
Timepoint
Beginning and end of the trial
Method of measurement
gene expression measurement with RT-PCR method
Secondary outcomes
1
Description
Body composition
Timepoint
Before intervention, and 3 months after intervention
Method of measurement
Measurement of body composition, including fat mass, fat free mass and total body water determination using bioelectrical impedance analyser (BIA)
Intervention groups
1
Description
Intervention group: This study is a double-blind placebo-controlled randomized clinical trial among volunteer obese patients who are willing to participate in the study by calling, after initial screening and checking the inclusion criteria, with The explanation regarding the purpose and method of studying the informed consent form will be completed. Then, during an interview with the participants, a personal profile questionnaire including (age, sex, job, education level, history of diseases, supplements and drugs, history of following a special diet, etc.), activity questionnaire validated body in Persian language IPAQ) and a three-day dietary recall form (two regular days and one day off of the week) at the beginning and end of the study and dietary data after converting to daily intake values to determine energy and macronutrients will be analyzed using Nutritionist IV software. Anthropometric measurements including height and weight will be measured at the beginning and once every two weeks until the end of the study. People's height was measured using a Seca stadiometer with an accuracy of 0.1 cm, their weight was measured using a Seca weighing scale with an accuracy of 100 grams (with minimal clothes and no shoes), and then waist circumference, waist circumference Hips and waist circumference will be estimated by standing height BMI. At the beginning and end of the study, 10 cc of blood will be taken from the subjects after 12 hours of fasting and the serum will be stored at -70°C until the time of measurement.Serum samples will be used to measure glycemic indices, lipid profile, liver enzymes. After 15 minutes of rest, people's blood pressure will be measured twice with an interval of 5 minutes, and the average blood pressure will be taken into account. Then, for randomly assigning people to two groups of 30 people, using RAS software, and based on 4 random blocks, people will be placed in intervention and control groups.The supplement group will take one boron tablet (1 capsule containing 10 mg of boron citrate per day before lunch) and the placebo group will take one tablet containing maltodextrin powder (before lunch) for 8 weeks.The pill containing the supplement and the placebo used in this study will be completely identical in appearance. The intervention group will receive tablets containing boron citrate supplement.
Category
Prevention
2
Description
Control group: This study is a double-blind placebo-controlled randomized clinical trial among volunteer obese patients who are willing to participate in the study by calling, after initial screening and checking the inclusion criteria, with The explanation regarding the purpose and method of studying the informed consent form will be completed. Then, during an interview with the participants, a personal profile questionnaire including (age, sex, job, education level, history of diseases, supplements and drugs, history of following a special diet, etc.), activity questionnaire validated body in Persian language IPAQ) and a three-day dietary recall form (two regular days and one day off of the week) at the beginning and end of the study and dietary data after converting to daily intake values to determine energy and macronutrients will be analyzed using Nutritionist IV software. Anthropometric measurements including height and weight will be measured at the beginning and once every two weeks until the end of the study. People's height was measured using a Seca stadiometer with an accuracy of 0.1 cm, their weight was measured using a Seca weighing scale with an accuracy of 100 grams (with minimal clothes and no shoes), and then waist circumference, waist circumference Hips and waist circumference will be estimated by standing height BMI. At the beginning and end of the study, 10 cc of blood will be taken from the subjects after 12 hours of fasting and the serum will be stored at -70°C until the time of measurement. Serum samples will be used to measure glycemic indices, lipid profile, liver enzymes. After 15 minutes of rest, people's blood pressure will be measured twice with an interval of 5 minutes, and the average blood pressure will be taken into account. Then, for randomly assigning people to two groups of 30 people, using RAS software, and based on 4 random blocks, people will be placed in intervention and control groups. The supplement group will take one boron tablet (1 capsule containing 10 mg of boron citrate per day before lunch) and the placebo group will take one tablet containing maltodextrin powder (before lunch) for 8 weeks. The pill containing the supplement and the placebo used in this study will be completely identical in appearance. The control group will receive tablets containing maltodextrin as placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
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
+98 914 116 3184
Email
helda.nutrition@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Tabriz University of Medical Sciences, Endocrine Research Center