The effect of combined training and Nutrition Bio-shield Superfood (NBS) Supplementation on some factors affecting Epigenetic Changes in Obese Men with Type 2 Diabetes
The effect of combined exercise and Nutrition Bio-shield Superfood (NBS) supplementation on some factors affecting epigenetic changes (CD36,DNMT3a, Betaine) and physical performance in obese men with type 2 diabetes
Design
The trial will be conducted in 4 groups, randomized, single-blind, and in Phase 2-3 on 48 patients.
Settings and conduct
The subjects will perform exercises in a gym under the supervision of a specialist. The subjects will also not know whether they are taking the supplement or a placebo.
Participants/Inclusion and exclusion criteria
1. Age range 45 to 55 years.
2. No specific disease
3. No limiting orthopedic conditions.
4. Walk independently and be able to perform daily tasks.
5. Medication dosage has not changed in the past month.
6. No history of regular exercise in the past three months (Yuemin Chen et al., 2015).
7. No smoking
8. Have a medical certificate from a specialist to confirm the ability to perform physical activity.
9. Uncontrolled arrhythmia
No insulin injection
Intervention groups
Combined exercises (resistance and aerobic) and Nutrition Bio-shield Superfood (NBS) supplementation. The exercises will be performed three times a week and the supplementation will be taken daily at a rate of 10 drops, equivalent to half a gram.
The control group will only receive a placebo, which is similar to the supplement in question.
Main outcome variables
Changes in blood levels of DNMT3a (measured by ELISA), plasma Betaine concentration (measured by enzymatic assay), and CD36 expression/level (measured by ELISA) after 12 weeks of combined exercise training plus NBS supplementation in 48 patients with type 2 diabetes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260607069676N1
Registration date:2026-06-20, 1405/03/30
Registration timing:prospective
Last update:2026-06-20, 1405/03/30
Update count:0
Registration date
2026-06-20, 1405/03/30
Registrant information
Name
Mohammad Khosravi Bakhtiari
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 3751 1058
Email address
mohammadkgb79@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-09-22, 1405/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined training and Nutrition Bio-shield Superfood (NBS) Supplementation on some factors affecting Epigenetic Changes in Obese Men with Type 2 Diabetes
Public title
The effect combined training and NBS Supplementation on Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No specific disease such as acute psychiatric disorders, cardiovascular, respiratory diseases, heart surgery, autoimmune diseases and arthritis.
No limiting orthopedic conditions.
Walk independently and be able to perform daily tasks.
The dose of the medication has not changed in the past month.
No history of regular exercise in the past three months
No smoking
Have a medical certificate from a specialist to confirm the ability to perform physical activity
Uncontrolled arrhythmia
Severe hearing impairment
No insulin injection
Exclusion criteria:
Failure to attend the training program for three consecutive sessions
Personal problems
Unwillingness to continue the research
Injury
Engaging in side activities
Use of herbal supplements other than those used in the plan or chemical supplements
Age
From 45 years old to 55 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after selecting the subjects, the subjects will be randomly divided into four groups. Simple Random Assignment is the method used for this purpose. In this method, each subject is assigned independently of the others and with equal probability (25%) to one of the four groups (combined exercise and supplementation, combined exercise and placebo, supplementation, placebo). Random assignment will be done using valid statistical software (such as SPSS, R or Excel) and using a random number generator.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, single-blinding will be used to control for potential bias and increase the validity of the findings. This means that subjects will be unaware of the type of intervention they are receiving (supplement or placebo) throughout the study.
To implement this method, the supplement and placebo will be completely similar and indistinguishable in appearance, color, odor, taste, packaging, and method of administration. The products will be distributed by a third party (research collaborator) or using confidential codes so that subjects cannot identify whether they are in the intervention or control group.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hakim Sabzevari University
Street address
Sabzevar, Tohidshahr, Pardis University
City
sabzevar
Province
Razavi Khorasan
Postal code
۹۶۱۷۹۷۶۴۸۷
Approval date
2026-06-07, 1405/03/17
Ethics committee reference number
IR.HSU.REC.1405.005
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
cd36
Timepoint
Before the intervention and 72 hours after the last intervention session
Method of measurement
ELISA laboratory kit
2
Description
Betaine
Timepoint
Before the intervention and 72 hours after the last intervention session
Method of measurement
ELISA laboratory kit
3
Description
DNMT3a
Timepoint
Before the intervention and 72 hours after the last intervention session
Method of measurement
ELISA laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Combined exercise and NBS supplementation. Perform three sessions of resistance and aerobic exercise and take 10 drops of the supplement daily, equivalent to half a gram.
Category
Treatment - Drugs
2
Description
Intervention group 2: Combined exercise and placebo
Category
Treatment - Devices
3
Description
Intervention group3: NBS supplement. Dosage is the same as in the first group.
Category
Treatment - Drugs
4
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian Clinic
Full name of responsible person
Ms. Farahmand
Street address
Bahar Street, after Jihad Street
City
mashhad
Province
Razavi Khorasan
Postal code
9136815512
Phone
+98 939 270 5648
Email
e.farahmand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Roya Askari
Street address
Tohid Shahr, University Campus
City
sabzevar
Province
Razavi Khorasan
Postal code
۹۶۱۷۹۷۶۴۸۷
Phone
+98 915 571 2509
Email
r.askari@hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Sabzevari University
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
Hakim Sabzevari University
Full name of responsible person
Mohammad Khosravi Bakhtiari
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Khaje rabie, 22 bahman Blvd, 22 bahman4/23, number 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9199786766
Phone
+98 51 3751 1058
Fax
Email
mohammadkgb79@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
دانشگاه حکیم سبزواری
Full name of responsible person
Mohammad Khosravi Bakhtiari
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Khaje rabie, 22 bahman Blvd, 22 bahman4/23, number 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9199786766
Phone
+98 51 3751 1058
Fax
Email
mohammadkgb79@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Mohammad Khosravi Bakhtiari
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Khaje rabie, 22 bahman Blvd, 22 bahman4/23, number 4
City
Mashhad
Province
Razavi Khorasan
Postal code
9199786766
Phone
+98 51 3751 1058
Fax
Email
mohammadkgb79@yahoo.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
Some information such as age, gender, weight, medical condition, medications taken
When the data will become available and for how long
12 months after results are published
To whom data/document is available
University professors and students
Under which criteria data/document could be used
Use for scientific activities
From where data/document is obtainable
Send email to:
Mohammadkgb79@yahoo.com
What processes are involved for a request to access data/document