Protocol summary

Study aim
The purpose of this research is to investigate the effect of eight weeks of HIIT training along with thyme consumption on the serum levels of omentin, FGF-21, irisin, adropin and nesfatin-1.
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, with supplements and placebo on 48 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Intervention - The city of Golpayegan is the location of Golpayegan University of Technical and Engineering research, for which the necessary arrangements have already been made. The present research method was field based. After calling and selecting the qualified people, the consent form for participating in the research was completed by the subjects and then the people were randomly placed in the periodic training, thyme, periodic training + thyme and control groups. The interval training group did intense interval training for 8 weeks. The thyme group received thyme supplement capsules (a product of Barij Essence Company) three times a day for 8 weeks. The intermittent exercise + thyme group underwent both exercise and thyme consumption. In the control group, the girls continued their normal life with placebo. In this research, the researcher and the participants were blinded.
Participants/Inclusion and exclusion criteria
Entry criteria include being in the desired age range, not having nutritional sensitivities, not having movement problems, and not having a regular sports history for at least the last 6 months. And the non-entry criteria include underlying diseases, skeletal complications, smoking, and nutritional sensitivities.
Intervention groups
Interval training group, Thyme group, Interval training + thyme group, Control group
Main outcome variables
Omentin, FGF-21, Irisin, Adropin, Nesfatin-1

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240413061479N1
Registration date: 2024-05-09, 1403/02/20
Registration timing: retrospective

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Zahra Mohseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 272 3747
Email address
zahra.mohsenin1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
2023-09-23, 1402/07/01
Actual recruitment end date
2023-11-06, 1402/08/15
Trial completion date
empty
Scientific title
The effect of eight weeks of high intensity interval training combined with thyme extract on serum levels of omentin, FGF-21, irisin, adropin and nesfatin-1 in sedentary young girls
Public title
The effect of exercise training and consumption of thyme supplements on anti-inflammatory factors in sedentary girls
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the desired age range Not having nutritional sensitivities Lack of regular sports history at least in the last 6 months Not having movement problems
Exclusion criteria:
Smoking Nutritional sensitivities Underlying diseases Having a history of regular sports activity in the last few months
Age
From 18 years old to 22 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 48
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, after selecting the eligible subjects, the subjects were selected by simple random method with the rule of random allocation. To place each subject in one of the four groups, a lottery was done in Excel; In this way, the list of participants was entered in one column in Excel. Then the RAND function was used to assign a random number to each cell (1 to 48). After that, names were extracted from the original list returned by RANDBETWEEN using the Index Rank function randomly and based on the row number. Finally, using Index Rank, four groups were selected, each containing 12 participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study. Due to the fact that the researcher and the subjects are not aware of the group and supplement consumed, a third person who is not aware of the objectives of the study will perform the supplement and groupings. Also, the third person codes them randomly and will be presented to the researcher with the code. It should be noted that all subjects will be informed about the research and objectives, but they will not be given information about which group they are in. Data analysis will also be done by a biostatistician outside the group who has no knowledge about the subjects.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, North Tehran branch
Street address
Shahid Abbaspur boulevard -Hakimiya exit
City
Tehran
Province
Tehran
Postal code
۱۶۵۱۱۵۳۳۱۱
Approval date
2023-09-03, 1402/06/12
Ethics committee reference number
IR.IAU.TNB.REC.1402.091

Health conditions studied

1

Description of health condition studied
Inactivity and systemic inflammation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nesfatin_1
Timepoint
Blood sampling in two periods before the test and after the test
Method of measurement
Eliza Kit. SUNLONG brand. Model No. SL2458 Hu

2

Description
Omentin
Timepoint
Blood sampling in two periods before the test and after the test
Method of measurement
Eliza Kit. SUNLONG brand. Model No. SL1293 Hu

3

Description
Irisin
Timepoint
Blood sampling in two periods before the test and after the test
Method of measurement
Eliza Kit. SUNLONG brand. Model No. SL2020 Hu

4

Description
FGF_21
Timepoint
Blood sampling in two periods before the test and after the test
Method of measurement
Eliza Kit. SUNLONG brand. Model No. SL2362 Hu

5

Description
Adropin
Timepoint
Blood sampling in two periods before the test and after the test
Method of measurement
Eliza Kit. SUNLONG brand. Model No. SL3231 Hu

6

Description
Vo2max
Timepoint
Pre-test, and the end of week 8
Method of measurement
Bruce's test

Secondary outcomes

1

Description
Body weight
Timepoint
Pre test and post test
Method of measurement
Digital scale (SECA model 703, made in Germany) with an accuracy of 0.05 kg

2

Description
Body composition
Timepoint
Pre test and post test
Method of measurement
Body composition device, Mediana brand, i30 model

Intervention groups

1

Description
Control group: This group continued their normal life with placebo for eight weeks.Thyme and placebo were prepared in the same way, and in the control group, a placebo consisting of starch powder in the form of 20 mg capsules was used, similar to the thyme capsules made in Barij Essan Company.
Category
Placebo

2

Description
The first intervention group: Thyme group: This group used Barij Essence Gastrolit 20 mg soft capsules (Barij Essence Gastrolit 20 mg, made in Iran) for 8 weeks, 3 times a day and half an hour before food.
Category
Other

3

Description
The second intervention group: Interval training group: For 8 weeks, they did intense interval training 3 times a week in a laboratory environment. The exercise protocol was performed with 90 to 95% of the maximum oxygen consumption of people on the treadmill
Category
Rehabilitation

4

Description
The third intervention group: Interval exercise + thyme group: this group did both interval exercise and took thyme supplements for 8 weeks. In order to prevent the acute effect of the supplement on sports performance, a 3-hour interval was placed between supplement consumption and interval training.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Golpayegan Technical University of Engineering
Full name of responsible person
Dr. Iman Golmohammadi
Street address
Moalem Square
City
Golpayegan
Province
Isfehan
Postal code
8771767498
Phone
+98 31 5724 0065
Email
Publicrel@gut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Samaneh Yazdani
Street address
Islamic Azad University, North Tehran branch، Hakimiya exit, Shahid Babaei highway
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7731 7742
Email
ravabet-omomi@iau-tnb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Mohseni
Position
PhD Student of Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Hakimiya exit, Shahid Babaei highway
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7700 9838
Email
zahra.mohsenin1995@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Bahram Abedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Hakimiye exit, Shahid Babaei highway
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7700 9838
Email
abedi_bahram2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Mohseni
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
No. 17 , Bahar Ave. , Parkeshahr squer
City
Golpayegan
Province
Isfehan
Postal code
8771685981
Phone
+98 31 5743 0054
Email
zahra.mohsenin1995@gmail.com

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
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