Protocol summary

Study aim
To investigate the effects of two training methods — electrical muscle stimulation (EMS) and high-intensity functional training (HIFT) — on FTO gene expression and metabolic functions (including fasting glucose, serum insulin, serum leptin, and insulin resistance) in obese men.
Design
A semi-experimental, three-arm, randomized controlled trial with a control group. The target population will be randomly allocated into three groups: (1) electrical muscle stimulation, (2) high-intensity functional training, and (3) control.
Settings and conduct
The study will be conducted in Shiraz, Iran. The exercise intervention will be implemented over 8 weeks, with a frequency of three sessions per week, under the direct supervision of the researcher. Fasting blood samples will be collected from the brachial vein of participants before the intervention and 24 hours after the final training session.
Participants/Inclusion and exclusion criteria
The study population comprises sedentary obese men in Shiraz with a mean age of 30–40 years and a body mass index (BMI) of 30–35 kg/m². Forty-five eligible participants will be selected through convenience sampling. Inclusion criteria include the absence of cardiovascular, renal, hepatic, or respiratory (asthma) disease; no musculoskeletal abnormalities; no history of surgery; no use of supplements or medications; no regular exercise participation within the past 6 months; and no use of tobacco or alcohol.
Intervention groups
Group 1: Electrical muscle stimulation (EMS) — 8 weeks, 3 sessions/week, 20 minutes per session Group 2: High-intensity functional training (HIFT) — 8 weeks, 3 sessions/week Group 3: Control (no intervention)
Main outcome variables
FTO gene expression (measured via quantitative real-time PCR), fasting glucose, fasting serum insulin, serum leptin, and insulin resistance (HOMA-IR).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191210045690N1
Registration date: 2026-08-31, 1405/06/09
Registration timing: registered_while_recruiting

Last update: 2026-08-31, 1405/06/09
Update count: 0
Registration date
2026-08-31, 1405/06/09
Registrant information
Name
Homa Sheikhani Shahin
Name of organization / entity
Zand Institute of Higher Education
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 1041
Email address
hsheikhani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-21, 1405/04/30
Expected recruitment end date
2026-09-21, 1405/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effects of two training methods: electrical muscle stimulation (EMS) and high-intensity functional training (HIFT) on FTO gene expression and metabolic functions in obese men
Public title
The Effects of EMS and HIFT on FTO gene expression and metabolic functions
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mass Index between 30 and 35 kg/m², No history of cardiovascular disease, renal failure, liver failure, or asthma, No musculoskeletal abnormalities, No history of surgery, No use of any supplements or medications, No history of regular participation in exercise training for at least 6 months prior to the start of the study, No tobacco use or alcohol consumption
Exclusion criteria:
Age
From 30 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
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 Shiraz University
Street address
Republic of Islamic Boulevard
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Approval date
2026-07-21, 1405/04/30
Ethics committee reference number
IR.US.PSYEDU.REC.1405.083

Health conditions studied

1

Description of health condition studied
FTO gene expression and metabolic functions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
FTO gene expression
Timepoint
Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training
Method of measurement
Real Time-PCR

2

Description
Serum Leptin
Timepoint
Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training
Method of measurement
ELISA (Enzyme-Linked Immunosorbent Assay)

3

Description
Fasting Plasma Glucose
Timepoint
Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training
Method of measurement
Glucose oxidase enzymatic method

4

Description
Serum Insulin
Timepoint
Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training
Method of measurement
Radioimmunoassay

5

Description
Insulin Resistance
Timepoint
Before starting the intervention and eight weeks after performing electrical muscle stimulation an high-intensity functional training
Method of measurement
Homeostatic model assessment of insulin resistance

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Behavior

2

Description
Control group:
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bitaran laboratory
Full name of responsible person
Iman Jamhiri
Street address
No. 52, Alley 11, Haft Tanan Boulevard
City
Shiraz
Province
Fars
Postal code
9217248010
Phone
+98 71 3732 7801
Email
bitaran.vetlab@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Street address
Alley 12, Iman South Boulevard
City
Shiraz
Province
Fars
Postal code
7188773489
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zand Institute of Higher Education
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Alley 12, Iman South Boulevard
City
Shiraz
Province
Fars
Postal code
7188773489
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Alley 12, Iman South Boulevard
City
Shiraz
Province
Fars
Postal code
7188773489
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zand Institute of Higher Education
Full name of responsible person
Homa Sheikhani Shahin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Alley 12, Iman South Boulevard
City
Shiraz
Province
Fars
Postal code
7188773489
Phone
+98 71 3632 1041
Email
hsheikhani@yahoo.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
Individual participant data will not be shared due to the need to protect participants’ confidentiality and privacy and to prevent potential identification of individual participants. Sharing individual-level data may also be inconsistent with ethical requirements and the scope of informed consent obtained from the participants. The study results will be reported and published in an aggregated form without any identifiable participant information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Individual participant data include demographic information, laboratory findings, FTO gene expression, and other metabolic indicators. Individual-level data will not be publicly released or made openly accessible, and the study findings will be reported in an aggregated and non-identifiable form.
When the data will become available and for how long
Individual participant data will not be made publicly accessible after completion of the study.
To whom data/document is available
Individual participant data will be accessible only to authorized members of the research team and solely for research purposes.
Under which criteria data/document could be used
Individual participant data will not be publicly shared. If access is scientifically justified, data may only be used subject to protection of participants’ confidentiality, ethical requirements, and the necessary approvals.
From where data/document is obtainable
In case of a justified scientific request, the request should be submitted to the principal investigator of the study.
What processes are involved for a request to access data/document
An access request should be formally submitted and reviewed for scientific and ethical considerations. If approved and the necessary permissions are obtained, only the required non-identifiable data will be provided to the requester.
Comments
To protect participants’ privacy and confidentiality, identifiable individual-level data will not be publicly released. The study findings will be reported in the master’s thesis and submitted for publication in a scientific journal.
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