1. Home
  2. Approved trials
  3. » فارسی

Effects of N-acetylcysteine on the expression of UCP1, didinase type 2 and 3, as well as thyroid hormone receptors alpha and beta in visceral adipose tissue of obese adults

Protocol summary

Study aim
Determining the effects of N-acetylcysteine on the expression of UCP1, didinase type 2 and 3, as well as thyroid hormone receptors alpha and beta in visceral adipose tissue of obese adults
Design
A clinical trial with a control group, with parallel groups, randomized, phase 3, double-blind on 50 obese adults. Random allocation will be used as Stratified Randomization using the Permuted block randomization method with quadruple and double blocks.
Settings and conduct
This study will be conducted in the surgery and obesity clinic of Imam Hussein Hospital (Tehran, Iran) on 50 obese adults. The study will be conducted in a double-blind manner with a control group. Due to the double-blindness of the study, before the start of the study, the sets of cans containing capsules will be prepared by someone other than the researcher, and the placebo will be similar in appearance to the intervention group. The intervention group will receive 600 mg N-acetylcysteine per day and the control group will receive 600 mg placebo per day for 6 weeks. At the beginning and after 6 weeks, the different effects of the intervention on these people are examined and compared.
Participants/Inclusion and exclusion criteria
Entry requirements: People with obesity with a body mass index (BMI) greater than or equal to 30 kg/m2, Age over 25 years, Non-pregnant, Non-lactating, Not suffering from chronic and acute inflammatory, and infectious diseases, Not suffering from high blood pressure and vascular diseases, Not receiving alcohol and smoking, Not participating in other clinical trial studies at the same time as the present study, Not receiving weight loss and antioxidant drugs and supplements in the last three months.
Intervention groups
The intervention and control groups will receive 600 mg of N-acetylcysteine supplement and placebo 6 weeks before sleeve surgery, respectively.
Main outcome variables
Weight, expression of UCP1, didinase type 2 and 3, thyroid hormone receptors alpha and beta

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220727055563N2
Registration date: 2023-07-01, 1402/04/10
Registration timing: prospective

Last update: 2023-07-01, 1402/04/10
Update count: 0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Hamid Zand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 7424
Email address
hamidzand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-20, 1402/04/29
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of N-acetylcysteine on the expression of UCP1, didinase type 2 and 3, as well as thyroid hormone receptors alpha and beta in visceral adipose tissue of obese adults
Public title
Effects of N-acetylcysteine on the expression of UCP1, didinase type 2 and 3, as well as thyroid hormone receptors alpha and beta in visceral adipose tissue of obese adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese people with a body mass index greater than or equal to 30 kg/m2.Age over 25 years Non-pregnant and lactating Not suffering from chronic and acute inflammatory, and infectious diseases Not suffering from high blood pressure and vascular diseases Not receiving alcohol and smoking
Exclusion criteria:
Receiving weight loss and antioxidant drugs and supplements in the last three months Participating in other clinical trial studies at the same time as the present study. Adherence to weight loss diets during the last three months. History of gastrointestinal or bariatric surgeries.
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used as Stratified Randomization using the Permuted block randomization method with quadruple and double blocks. According to the sample size of 70 that has been determined, the quadruple and double blocks will be produced using the software. In the Stratified Randomization method, age and BMI will be used as layers. In order to apply concealment in the randomization process, unique codes will be used on medicine boxes, and the desired code will be generated by the software. As each person enters the study based on the generated sequence, the drug package in which the desired code is recorded will be assigned to the person, and therefore, before choosing the person, no one will be aware of the type of treatment that the person will receive. Also, the random sequence generated during the study will be immune to prediction.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. Participants will be divided into two groups receiving N-Acetylcysteine supplementation and the placebo group. Due to the double-blindness of the study, before starting the study, sets of cans containing N-Acetylcysteine supplementation will be prepared by someone other than the researcher, and the placebo will be similar in appearance to N-Acetylcysteine, so that the researcher does not know the type of treatment received by each group. In addition, the researcher in the evaluation phase of the desired outcomes (measurements of biochemistry and related gene expression) from the allocation of participants in each of the groups (intervention and control group) until after the end of the intervention period will be uninformed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of National Nutrition & Food Technology Research Institute
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1402.012

Health conditions studied

1

Description of health condition studied
Obesity adults
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Expression of UCP1 genes
Timepoint
At the end of week 6
Method of measurement
Using PCR (polymerase chain reaction)

Secondary outcomes

1

Description
Expression of didinase type 2 and 3 genes
Timepoint
The end of week 6
Method of measurement
Using PCR (polymerase chain reaction)

2

Description
Expression of alpha and beta thyroid hormone receptor genes
Timepoint
The end of week 6
Method of measurement
Using PCR (polymerase chain reaction)

3

Description
Serum level of thyroid hormones (TSH, T3 and T4)
Timepoint
At the beginning of the study and at the end of week 6
Method of measurement
Blood sampling and measurement by ELISA method

Intervention groups

1

Description
Intervention group: Daily 600 mg of NAC supplement prepared by Osvah Pharmaceutical Company of Iran for 6 weeks
Category
Treatment - Drugs

2

Description
Control group: Daily 600 mg maltodextrin supplement prepared by Karen Pharmaceutical Company of Iran for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Hamid Zand
Street address
Imam Hossein (AS) Medical Research Training Center, Shahid Madani St, Tehran.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi, Vice President of Research and Technology, Shahid Beheshti University
Street address
Building No. 2 - 5th floor, Shahid Arabi St., Yemen St., Shahid Chamran highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid Zand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2235 7483
Email
hamidzand@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid Zand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2235 7483
Email
hamidzand@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid Zand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2235 7483
Email
hamidzand@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Information on the main implications can be shared at the end of the study.
When the data will become available and for how long
The access period will be 6 months after the results are published.
To whom data/document is available
The data from this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
6 months after the publication of the articles obtained from the data of this project, at the request of the person in charge of the project and his consent, the study data can be made available to researchers.
From where data/document is obtainable
-Applicants can contact the responsible author via email or the following mailing address to obtain the required data. Postal address:Tehran, Farahzadi Blvd., Tree St., Hafezi Alley, Faculty of Nutrition Sciences, Cellular-Molecular Group. Dr. Hamid Zand, email: hamidzand@gmail.com
What processes are involved for a request to access data/document
Applicants will be able to access the study data by sending an email to the responsible author within a maximum of one week.
Comments
Loading...