Protocol summary

Study aim
Investigating the effects of high-intensity multimodal and concurrent training on the abundance of gut bacteria associated with obesity, and body composition, physical fitness, lipid profile, blood glucose, and insulin sensitivity in overweight and obese men Investigating the relationship between changes in the abundance of gut bacteria associated with obesity, with changes in body composition, physical fitness, lipid profile, blood glucose, and insulin sensitivity in overweight and obese men
Design
A stratified, randomized, two-arm parallel group clinical trial with randomization based on BMI, age, and activity level, using the Excel random function, with at least 12 participants per group.
Settings and conduct
Participants will be recruited in Isfahan and, if eligible, will sign an informed consent. Blood and stool samples will be collected, and Body composition analysis and physical fitness tests will be performed. Participants will then be randomly assigned to one of two exercise protocols (high-intensity multimodal or concurrent training) for 2 months, three times a week. Blood tests for glucose and lipid profiles will be conducted in Isfahan, while stool samples will be stored at -80°C and sent to Tehran University’s Endocrinology and Metabolism Research Center.
Participants/Inclusion and exclusion criteria
Young men (18-40 years old) with a body mass index in the overweight or obese range (25-30) who are in proper physical condition to participate in the exercises and have no diseases, medications, or conditions that would significantly affect the gut microbiome.
Intervention groups
Intervention group 1: Undergo two months of high-intensity multimodal training. Intervention group 2: Undergo two months concurrent training.
Main outcome variables
Investigating and comparing the effects of high-intensity multimodal and concurrent training on obesity-related gut microbiota.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250220064782N1
Registration date: 2025-03-13, 1403/12/23
Registration timing: prospective

Last update: 2025-03-13, 1403/12/23
Update count: 0
Registration date
2025-03-13, 1403/12/23
Registrant information
Name
Kiana Sadat Hosseini Noushirvani
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 7707 8129
Email address
kiana.nooshirvani@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-15, 1403/12/25
Expected recruitment end date
2025-04-09, 1404/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of High-Intensity Multimodal Training and Concurrent Training on Gut Microbiota, Body Composition, and Metabolic Status in Overweight and Obese Men
Public title
Effects of high-intensity multimodal and concurrent training on gut microbiota and metabolism in obese and overweight men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Below-average physical activity level Body Mass Index between 25 and 35 No current cardiovascular diseases, diabetes, or gastrointestinal issues No musculoskeletal problems that would make exercise unsuitable or harmful for the individual No use of medications affecting gut function, steroid supplements, or weight-loss supplements No use of antibiotics at least one month prior to the start of the training period No regular consumption of alcohol and smoking
Exclusion criteria:
Disease or injury that interferes with the execution of exercises or the results of subsequent laboratory tests. Use of antibiotics or other medications mentioned in the inclusion criteria Withdrawal from the study due to lack of willingness to continue participation
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Unit of Randomization: Randomization will be performed at the individual level. Randomization Method: Stratified randomization based on Body Mass Index (overweight or class 1 obesity range) will be used to ensure a balanced distribution of this potential confounding variable between groups. Randomization Tool: The random sequence will be generated using the RAND function in Excel. Allocation Concealment and Blinding: Participants will not be informed of their assigned training group until the intervention begins. Due to the nature of the intervention, blinding of participants and trainers is not possible. However, outcome assessors for blood and microbiological tests will be blinded to group assignments.
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 the University of Tehran
Street address
No. 22, Building 21, Omid shahrak, Qanat Kowsar
City
Tehran
Province
Tehran
Postal code
1689763851
Approval date
2024-05-21, 1403/03/01
Ethics committee reference number
IR.UT.SPORT.REC.1403.027

Health conditions studied

1

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

Primary outcomes

1

Description
The abundance of selected gut bacteria associated with obesity
Timepoint
Before the intervention period and after the intervention period
Method of measurement
Utilizing a stool deoxyribonucleic acid extraction kit, followed by analysis using real-time polymerase chain reaction technique

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Participants who perform high-intensity multidimensional training three times a week for two months
Category
Treatment - Other

2

Description
Intervention group 2: Participants who perform concurrent training three times a week for two months
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
City of Isfahan
Full name of responsible person
Ebrahim Bagheri
Street address
No. 22, Building 21, Omid Shahrak, Qanat Kowsar
City
Tehran
Province
Tehran
Postal code
1689763851
Phone
+98 21 7707 8129
Email
kiana.nooshirvani@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Univercity of Tehran
Full name of responsible person
Alireza Haghighi
Street address
No. 22, Building 21, Omid Shahrak, Qanat Kowsar
City
Tehran
Province
Tehran
Postal code
1689763851
Phone
+98 21 7707 8129
Email
kiana_nooshirvani@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Isfahan
Proportion provided by this source
1
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
University of Tehran
Full name of responsible person
Kiana Sadat Hosseini Noushirvani
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Qanat Kosar, Omid Town, Building 21, No. 22
City
Tehran
Province
Tehran
Postal code
1689763851
Phone
+98 21 7707 8129
Fax
Email
kiana.nooshirvani@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Kiana Sadat Hosseini Noushirvani
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Qanat Kosar, Omid Town, Building 21, No. 22
City
Tehran
Province
Tehran
Postal code
1689763851
Phone
+98 21 7707 8129
Fax
Email
kiana.nooshirvani@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Kiana Sadat Hosseini Noushirvani
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Qanat Kosar, Omid Town, Building 21, No. 22
City
Tehran
Province
Tehran
Postal code
1689763851
Phone
+98 21 7707 8129
Fax
Email
kiana.nooshirvani@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...