The effect of twelve weeks of high-intensity functional training with spinach-derived thylakoid supplementation on some inflammatory and antioxidant markers, adipokines, myokines, and hepatokines in men with obesity
The effect of twelve weeks of high-intensity functional training with spinach-derived thylakoid supplementation on some inflammatory markers in men with obesity
Design
Clinical trial with parallel control group, randomized, single-center trial, Sample size 44 people, Blinding is not done.
Settings and conduct
Twelve weeks of high-intensity functional training with spinach-derived thylakoid supplementation for 44 obese men. Tehran health centers
Participants/Inclusion and exclusion criteria
Inclusion criteria: No addiction to drugs and alcohol; Not having a history of regular sports activity for at least 6 months; No history of disease; Not having any injury or physical problem; Body mass index equal to 30; Waist-to-height ratio greater than 0.5
Exclusion Criteria: Any psychological disorder; Use of psychiatric drugs before conducting study
Intervention groups
Intervention group1: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes, in which CrossFit is used.
Intervention group2: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes. Daily, one bag containing 5 grams of thylakoid will be dissolved in a glass of water and given to the participants.
Intervention group3: In this group, they will only do their daily exercises for 12 weeks. and daily, one bag containing 5 grams of thylakoid will be dissolved in a glass of water and given to the participants.
Control group: In this group, they will only do their daily exercises for 12 weeks and will be prohibited from participating in regular activities. Daily, one bag containing 5 grams of corn starch powder (placebo) will be dissolved in a glass of water and given to the participants.
Main outcome variables
Adipokines, Myokines, Hepatokines
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N77
Registration date:2023-04-26, 1402/02/06
Registration timing:prospective
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of twelve weeks of high-intensity functional training with spinach-derived thylakoid supplementation on some inflammatory and antioxidant markers, adipokines, myokines, and hepatokines in men with obesity
Public title
The effect of twelve weeks of high-intensity functional training with spinach-derived thylakoid supplementation on some inflammatory markers in men with obesity
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
No addiction to drugs and alcohol
Not having a history of regular sports activity for at least 6 months
No history of kidney, liver, cardiovascular disease and diabetes
Not having any injury or physical problem
Body mass index equal to 30
Waist-to-height ratio (WHtR) greater than 0.5
Exclusion criteria:
Any psychological disorder to the individual's own report
Use of psychiatric drugs before conducting study
Age
From 23 years old to 32 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA, and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 11 units of 4 blocks will be selected so that we consider having 11 people in the group (A), 11 people in the group (B), 11 people in the group (C) and 11 people in the group (D). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
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, Damghan branch
Street address
Islamic Azad University, Damghan branch; above Saadi square; Damghan.
City
Damghan
Province
Semnan
Postal code
3671637849
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.IAU.DAMGHAN.REC.1401.034
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Body mass index
Timepoint
48 hours before the intervention and 48 hours after the twelve-week training period
Method of measurement
Weight with kilograms on a scale - Height with meters with the use of a rubber meter
Secondary outcomes
1
Description
Myokines
Timepoint
The first fasting blood sample 48 hours before and the second blood sample 48 hours after the twelve-week training period from the right arm
Method of measurement
They will be measured using laboratory kits and ELISA devices
2
Description
Hepatokines
Timepoint
The first fasting blood sample 48 hours before and the second blood sample 48 hours after the twelve-week training period from the right arm
Method of measurement
They will be measured using laboratory kits and ELISA devices
3
Description
Adipokines
Timepoint
The first fasting blood sample 48 hours before and the second blood sample 48 hours after the twelve-week training period from the right arm
Method of measurement
They will be measured using laboratory kits and ELISA devices
Intervention groups
1
Description
Intervention group1: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes, in which CrossFit is used.
Category
Treatment - Other
2
Description
Intervention group2: In this group, according to the protocol, they will perform a high-intensity functional training program (HIFT) in 36 sessions of 60 minutes, in which CrossFit is used. Daily, one bag containing 5 grams of thylakoid will be dissolved in a glass of water and given to the participants 30 minutes before lunch.
Category
Treatment - Other
3
Description
Intervention group3: In this group, no treatment will be given and they will only do their daily exercises for 12 weeks and will be prohibited from participating in regular activities. Daily, one bag containing 5 grams of thylakoid will be dissolved in a glass of water and given to the participants 30 minutes before lunch. It is only for comparison with intervention groups.
Category
Treatment - Other
4
Description
Control group: In this group, no treatment will be given and they will only do their daily exercises for 12 weeks and will be prohibited from participating in regular activities. Daily, one bag containing 5 grams of corn starch powder (placebo) will be dissolved in a glass of water and given to the participants 30 minutes before lunch. It is only for comparison with intervention groups.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran health centers
Full name of responsible person
Ayoub Saeidi
Street address
Payandeh St., Iranmehr St., Tehran
City
Tehran
Province
Tehran
Postal code
1714956543
Phone
+98 21 3379 1873
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nemat Allah Nemati
Street address
Islamic Azad University, Damghan branch; above Saadi square; Damghan.
City
Damghan
Province
Semnan
Postal code
3671637849
Phone
+98 23 3522 5045
Email
info@damghaniau.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
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
Islamic Azad University
Full name of responsible person
Ayoub Saeidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical education and sports sciences - sports physiology
Street address
Islamic Azad University, Damghan branch; above Saadi square; Damghan.
City
Damghan
Province
Semnan
Postal code
3671637849
Phone
+98 23 3522 5045
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ayoub Saeidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical education and sports sciences - sports physiology
Street address
Islamic Azad University, Damghan branch; above Saadi square; Damghan.
City
Damghan
Province
Semnan
Postal code
3671637849
Phone
+98 23 3522 5045
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ayoub Saeidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical education and sports sciences - sports physiology
Street address
Islamic Azad University, Damghan branch; above Saadi square; Damghan.
City
Damghan
Province
Semnan
Postal code
3671637849
Phone
+98 23 3522 5045
Email
are20935@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