Investigating the effect of zinc supplementation on the levels of oxidative stress and inflammation markers and glucose homeostasis in overweight or obese patients with metabolic syndrome
Investigating the effect of zinc supplementation on the levels of oxidative stress and inflammation markers and glucose homeostasis in overweight or obese patients with metabolic syndrome
Design
In this clinical trial, which is a prospective, randomized, controlled ,parallel and double-blind study, 60 patients with metabolic syndrome will be selected . Patients are divided into two groups A (30 patients) and B (30 patients) based on admission number and using a table of random numbers.
Settings and conduct
The location of the study will be Dr. Shakri's clinic in Bojnord, North Khorasan. The field of study is the findings of previous studies about the antidiabetic effects of zinc. Blinding is done to the clinical doctor and the studied patients.
Participants/Inclusion and exclusion criteria
Patients over 18 to 70 years old with metabolic syndrome
Inclusion criteria:
Overweight or obesity (BMI above 25)
Exclusion criteria:
Taking zinc supplements for at least three months before the start of the study
Intervention groups
Patients with metabolic syndrome receiving zinc supplementation, patients with metabolic syndrome receiving placebo
Main outcome variables
Levels of markers of oxidative stress and inflammation and glucose homeostasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240125060804N1
Registration date:2024-01-31, 1402/11/11
Registration timing:prospective
Last update:2024-01-31, 1402/11/11
Update count:0
Registration date
2024-01-31, 1402/11/11
Registrant information
Name
Mostafa Vaghari-Tabari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 2963
Email address
vagharim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of zinc supplementation on the levels of oxidative stress and inflammation markers and glucose homeostasis in overweight or obese patients with metabolic syndrome
Public title
Investigating the effects of zinc in reducing the risk of diabetes and cardiovascular diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 to 70 years old
Definite diagnosis of metabolic syndrome based on clinical symptoms and laboratory findings.
Overweight or obesity (BMI above 25)
Obtaining written informed consent from patients
Exclusion criteria:
Taking zinc supplements at least three months before starting the study
The need to take blood sugar and lipid lowering drugs according to the doctor's opinion
History of other diseases related to oxidative stress and inflammation such as cardiovascular diseases, autoimmune diseases, types of diabetes, IBD, asthma, cancer, kidney and liver diseases, Infectious diseases
Smoking and alcohol consumption
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study, after applying the inclusion and exclusion criteria, patients will be divided into two groups to receive zinc supplements (30 patients) and placebo (30 patients). Randomization will be done using a computer-generated random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of the clinical researcher and patients will be done. The zinc supplement and placebo will be delivered to the clinical researcher with identical appearance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University, Shahrood Branch
Street address
Islamic Azad University, Shahrood branch, University blvd
City
Shahrood
Province
Semnan
Postal code
43189-36199
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1402.072
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Serum insulin
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Commercial ELISA kit
2
Description
Serum MDA
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
TBARS method
3
Description
Serum zinc
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Commercial spectrophotometry kit
4
Description
Serum total antioxidant capacity
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
FRAP method
5
Description
Serum lipid profile
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Commercial spectrophotometry kit
6
Description
Serum CRP
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Commercial kit
7
Description
Serum TNF-α
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Commercial ELISA kit
8
Description
HbA1C levels
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Commercial kit
9
Description
Serum fasting glucose
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Commercial kit
10
Description
Body Mass Index
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Scales, meter
11
Description
Waist circumference
Timepoint
Before the intervention, after the end of the intervention period
Method of measurement
Meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with metabolic syndrome receiving zinc supplementation. The dose of zinc received will be 30 mg orally once a day. Supplementation will be done for 12 weeks.
Category
Prevention
2
Description
Control group: Patients with metabolic syndrome receiving placebo. The placebo will be starch tablets, similar in appearance to zinc tablets, and will be taken once a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shakri's endocrinology clinic
Full name of responsible person
Habibeh Sadat Shakeri
Street address
1st Floor, Doctors Building, Dr. Hekmati Alley, South Shariati St.
City
بجنورد
Province
North Khorasan
Postal code
9414864157
Phone
+98 58 3222 6606
Email
drhssh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behrooz yahyaee
Street address
Islamic Azad University, Shahrood branch, University blvd
City
Shahrud
Province
Semnan
Postal code
43189-36199
Phone
+98 23 3239 1890
Email
behroozyahyaei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Vaghari-Tabari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
At the end of Modares Alley, Jamal Alley, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4717975666
Phone
+98 11 3223 2963
Fax
Email
vagharim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Vaghari-Tabari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
At the end of Modares Alley, Jamal Alley, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4717975666
Phone
+98 11 3223 2963
Fax
Email
vagharim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Vaghari-Tabari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
At the end of Modares Alley, Jamal Alley, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4717975666
Phone
+98 11 3223 2963
Fax
Email
vagharim@tbzmed.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information related to the study can be shared
When the data will become available and for how long
Access starts six months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to the data will be given to people working in scientific and academic institutions only by citing scientific reasons, and all statistical analyzes on the data will be allowed.
From where data/document is obtainable
To receive the data, contact Mostafa Vaghari- Tabari via email mostafavaghari@yahoo.com or vagharim@tbzmed.ac.ir
What processes are involved for a request to access data/document
After correspondence with the responsible person, the scientific reasons for the data request will be discussed with all members of the research team, and if the reasons are scientific and there is no legal prohibition, the data will reach the requester within a week.