General Objective: To determine the relationship between the expression of cellular senescence genes and inflammatory factors with age in healthy individuals
Specific Objectives:
To determine the activity of the beta-galactosidase enzyme in peripheral blood mononuclear cells (PBMC) in case and control groups
To determine the expression of p16, p21 genes in peripheral blood mononuclear cells in case and control groups
Determination and comparison of TNFα, IL-6 gene expression in peripheral blood mononuclear cells in case and control groups
Determination of the relationship between p16, p21, TNFα and IL-6 gene expression in peripheral blood mononuclear cells and age in healthy subjects
Determination of the relationship between beta-galactosidase enzyme activity in peripheral blood mononuclear cells and age in healthy subjects
Design
Cross-sectional, observational, comparative, unblinded study on 39 people in each group
Settings and conduct
Healthy elderly people who meet the inclusion criteria for the case group and other healthy individuals aged 18-39 who meet the inclusion criteria for the control group and do not meet the exclusion criteria will be included in the study after obtaining informed consent
Participants/Inclusion and exclusion criteria
Inclusion criteria for the case group
body mass index of 25-32 kg/m2
Age over 65 years old
No acute or chronic infections and inflammations
No diabetes or thyroid diseases
Inclusion criteria for the control group:
body mass index of 18.5-24.9 kg/m2
-Age 18-39 years
- No acute or chronic infections and inflammations
Intervention groups
observational study
Main outcome variables
p21, p16, TNFα, IL-6 genes and beta-galactosidase activity, in PBMCs. The gene expression will be examined by Polymerase chain reaction (PCR) and the activity of beta-galactosidase will be examined by staining.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220727055563N3
Registration date:2026-05-18, 1405/02/28
Registration timing:prospective
Last update:2026-05-18, 1405/02/28
Update count:0
Registration date
2026-05-18, 1405/02/28
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
Not yet recruiting
Funding source
Expected recruitment start date
2026-07-21, 1405/04/30
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the expression of cellular senescence genes and inflammatory factors in two groups of elderly and young
Public title
Investigating biological age with cellular senescence genes in blood polynuclear cells
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
people with a body mass index of 18.5-24.9 kg/m2
Exclusion criteria:
Having other diseases that affect inflammation and cellular aging, including cancer
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of NNFTRI
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2025-07-23, 1404/05/01
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1404.038
Health conditions studied
1
Description of health condition studied
Investigating and comparing the expression of cellular senescence genes and inflammatory factors in healthy elderly and young
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Expression of senescence related genes in PBMCs
Timepoint
once
Method of measurement
In Blood
Secondary outcomes
empty
Intervention groups
1
Description
The study is an observational and comparative study between older and younger people.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran
Full name of responsible person
Hamid Zand
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd.
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Email
hamidzand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
hamidzand@gmail.com
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
City
Tehran
Province
Tehran
Postal code
1981619573
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
1981619573
Phone
+98 21 2207 7424
Fax
Email
hamidzand@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
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
Data can potentially be shared after individuals are de-identified.
When the data will become available and for how long
After the study is fully completed and the results are published in reputable scientific journals
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In cases where this data helps solve a problem in the area of research
From where data/document is obtainable
Main investigator
What processes are involved for a request to access data/document
Clearly state the reason for the request and the results of its use.