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The Effect of TRF and Exercise on Inflammatory,Metabolic and Hormonal Indicators in Overweight Men

Protocol summary

Study aim
Determining the effect of three methods of time restricted feeding (with 6-hour, 8-hour and 10-hour feeding windows) along with low intensity aerobic exercise on appetite regulating factors, body composition, inflammatory and metabolic indicators and hormones in overweight middle-aged men
Design
Interventional clinical trial without a control group, parallel groups with a different feeding window in terms of time but with the same exercise protocol, the number of volunteers is not yet known, there will be randomization, there is no blinding. Sample size in each group is 9 with G power software.
Settings and conduct
The place of study will be Mohaghegh Ardabili University. After selecting the subjects and distributing them randomly in the three groups, and holding training sessions for the groups, pre-intervention tests will be conducted and the study process will begin. After performing the different nutrition protocol and the same exercise in 6 and 12 weeks, the measurements will be done again. Because we need the informed cooperation of the subjects, there is no blinding.
Participants/Inclusion and exclusion criteria
Male with overweight employees working in the offices of Ardabil city
Intervention groups
1-Time restricted feeding(TRF) and low-intensity aerobic exercise group with a 6-hour feeding window (8-14) 2- TRF and low-intensity aerobic exercise group with an 8-hour feeding window (8-16) 3- TRF and low-intensity aerobic exercise group with a 10-hour feeding window (8-18)
Main outcome variables
Leptin, AGRP, ghrelin, insulin, glucose،cortisol, TNF-α, IL-6, CRP, energy intake and expenditure, Vo2 max, weight, fat percentage, waist circumference, hip circumference ,waist circumference to hip ratio

General information

Reason for update
Acronym
GTES
IRCT registration information
IRCT registration number: IRCT20230112057115N1
Registration date: 2023-03-09, 1401/12/18
Registration timing: registered_while_recruiting

Last update: 2023-03-09, 1401/12/18
Update count: 0
Registration date
2023-03-09, 1401/12/18
Registrant information
Name
Hamid Vasfi
Name of organization / entity
University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0274
Email address
h_vasfi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of TRF and Exercise on Inflammatory,Metabolic and Hormonal Indicators in Overweight Men
Public title
The effect of TRF and exercise on health indicators
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being male Age 35 to 55 years Body mass index 25 to 30
Exclusion criteria:
Pulmonary disease Having diabetes Suffering from other metabolic diseases Inflammatory diseases Suffering from cardiovascular diseases Having liver diseases
Age
From 35 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 9
More than 1 sample in each individual
Number of samples in each individual: 27
Blood plasma sampling for measuring the plasma concentration of blood glucose, insulin, cortisol, TNF-α, IL-6, CRP, leptin, AGRP, ghrelin for each person on three occasions (before the intervention, 6 weeks after the intervention and 12 weeks later of intervention)
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization model is used for the study.Subjects are randomly placed in one of the three study groups with the help of a random number table and receive the intervention related to the same group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of University of Guilan
Street address
Rasht, Persian Gulf Highway, Kilometer 5 Qazvin Road, Gilan University Complex
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Approval date
2022-12-28, 1401/10/07
Ethics committee reference number
IR.GUILAN.REC.1401.087

Health conditions studied

1

Description of health condition studied
Overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Measurement of height, weight and BMI
Timepoint
Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention
Method of measurement
اندازه گیری توسط وزنه دیجیتال و متر نواری

2

Description
Vo2max
Timepoint
Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention
Method of measurement
Measuring by tread mill and bulk test

3

Description
Measurement of body composition
Timepoint
Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention
Method of measurement
Using caliper and 7-point method and "Jackson-Palux" equation for bone density and "Siris" formula to obtain fat percentage

Secondary outcomes

1

Description
Fasting plasma concentrations of Glucose, insulin, cortisol
Timepoint
Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention
Method of measurement
Using glucose oxidase method to measure glucose concentration and ELISA technique to measure other blood factors in plasma

2

Description
Measurement of plasma concentration of leptin, AGRP, ghrelin
Timepoint
Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention
Method of measurement
ELISA technique

3

Description
Measurement of plasma concentration of TNF-α, IL6 CRP
Timepoint
Before the intervention, 6 weeks after the start of the intervention, 12 weeks after the intervention
Method of measurement
ELISA technique

Intervention groups

1

Description
Intervention group: The first group: TRF with a 6-hour feeding window (8-14) along with low-intensity aerobic exercise* The second group: TRF with an 8-hour feeding window (8-16) along with low-intensity aerobic exercise * The third group: TRF with a 10-hour feeding window (8-18) along with low-intensity aerobic exercise. There is no control group and the effect of independent variables of TRF and exercise on the study groups are compared with dependent variables in three occasions before the intervention, 6 weeks from the start of the intervention and 12 weeks from the start of the intervention. A comparison is made between the groups themselves in terms of the amount and intensity of changes in the dependent variables in these three times.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
دانشگاه ها، اداره جات
Full name of responsible person
hamid vasfi
Street address
No. 24, Sablan Alley 12, Ahan Foroshan, Sablan Phase I, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619766539
Phone
+98 45 3363 0332
Email
h_vasfi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
عارف نوری
Street address
اردبیل، انتهای خیابان دانشگاه، مجتمع اداری دانشگاه علوم پزشکی اردبیل
City
اردبیل
Province
Ardabil
Postal code
۸۵۹۹۱-۵۶۱۸۹
Phone
+98 45 3353 4790
Email
poshtibani@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
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
Gilan University
Full name of responsible person
Hamid Mohebbi
Position
Professor of the Faculty of Physical Education and Sports Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Rasht, Persian Gulf highway (kilometer 5 of the Rasht-Qazvin road), Gilan University Complex, Faculty of Physical Education and Sports Sciences
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
۸ -۳۳۶۹۰۲۷۴-۰۱۳
Email
mohebbi_h@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gilan University
Full name of responsible person
Hamid Mohebbi
Position
Gilan University Professor of the Faculty of Physical Education and Sports Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Rasht, Persian Gulf highway (kilometer 5 of the Rasht-Qazvin road), Gilan University Complex, Faculty of Physical Education and Sports Sciences
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
33690274-013
Email
mohebbi_h@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gilan University
Full name of responsible person
Hamid Mohebbi
Position
Professor of the Faculty of Physical Education and Sports Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Rasht, Persian Gulf highway (kilometer 5 of the Rasht-Qazvin road), Gilan University Complex, Faculty of Physical Education and Sports Sciences
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
33690274-013
Email
mohebbi_h@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
Our subjects are not sick, just overweight.
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The decision will be made after collecting the data.
When the data will become available and for how long
It is not clear at the moment.
To whom data/document is available
The decision will be made after collecting the data.
Under which criteria data/document could be used
The decision will be made after collecting the data.
From where data/document is obtainable
The decision will be made after collecting the data.
What processes are involved for a request to access data/document
The decision will be made after collecting the data.
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