Investigating the effect of HIFT and thylakoid supplementation on systemic inflammation parameters in obese people.
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 44 patients. Variable block method was used for randomization and people were divided into four groups. The participants in this project were all obese men of Tehran with the age range of 23-32 years, who were selected through a call in administrative and public centers. Blood samples were collected 48 hours before the start of the 16-week intervention and 48 hours after. Blood samples were collected and analyzed by the present staff in the laboratory.
Settings and conduct
1- Collecting the research background and approving the proposal
2- Calling for recruitment
3- Familiarization meeting and obtaining consent and completing the questionnaires
4- Grouping
5- Pre-test components
6- Implementation of the intervention
7- Implementation of the post-test
8- Data collection
9- Statistical analysis
10- Results report
A placebo was used for blinding so that the participants would not know who was using the drug, and a separate training coach was used for double blinding.
This study was conducted in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- The age between 23 and 32.
2- BMI is more than 30 kg/m2
3- Absence of chronic diseases
4- Not using any type of food supplement, smoking and alcohol, caffeine and drug treatment
5- The subjects did not have special diets during the last six months.
6- Subjects had little physical activity in normal and daily life during the past two months and did not have a regular exercise program during the past two years.
7- WHtR than 0.5
Exclusion criteria:
1- Absence of more than three sessions
2- Accident, physical injury
Intervention groups
Group 1: supplement (11 people)
Group 2: Training (11 people)
Group 3: Training and supplement (11 people)
Control group: People in this group had 16 weeks of daily life without participating in regular sports activities.
Main outcome variables
interleukin-1beta, interleukin-8, CRP protein, MCP-1, and semaphorin 3E (Sema3E).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240608062039N1
Registration date:2024-06-15, 1403/03/26
Registration timing:retrospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Heidar Ebadiasl
Name of organization / entity
University of guilan
Country
Iran (Islamic Republic of)
Phone
+98 35 3830 2188
Email address
h.ebadi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high-intensity functional training with thylakoid supplementation on some inflammatory indicators in obese men
Public title
The effect of exercise on inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not suffering from chronic diseases according to the medical history questionnaire (Cardiovascular diseases and diabetes or any injury or problem that limits them from participating in physical activity)
Not using any food supplement, smoking, alcohol and drug treatment
Not using low-calorie diets in the last 6 months
Not doing regular daily sports activities in the last two years
Not taking nutritional supplements
The ratio of waist circumference to height above 0.5
Exclusion criteria:
Age
From 23 years old to 32 years old
Gender
Male
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
11
Randomization (investigator's opinion)
Randomized
Randomization description
In the first session, the height and weight of all the subjects were taken and all the research steps were shown as well as how to do the exercise program with the subjects. In the second session, a maximum repetition test was taken from the subjects. Then, in another session, the subjects were homogeneously divided into 4 groups based on individual characteristics: 1) control (11 people), 2) supplement (11 people), 3) exercise (11 people), 4) exercise and supplement (11 people) .
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the researcher did not know whether it was a drug or a placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad Academic Center for Education, Culture and Research
Street address
Ferdosi university
City
Mashhad
Province
Razavi Khorasan
Postal code
8916713335
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.ACECR.JDM.REC.1402.016
Health conditions studied
1
Description of health condition studied
Obesity and inflammation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Levels Of interleukin-1beta
Timepoint
48 hours before and after intervention
Method of measurement
Blood sample
2
Description
Levels Of interleukin-8
Timepoint
48 hours before and after intervention
Method of measurement
Blood sample
3
Description
Levels Of interleukin-10
Timepoint
48 hours before and after intervention
Method of measurement
Blood sample
4
Description
Levels Of (Semaphorin-3E) SEMA-3E
Timepoint
48 hours before and after intervention
Method of measurement
Blood sample
5
Description
Levels Of fibrinogen protein
Timepoint
48 hours before and after intervention
Method of measurement
Blood sample
6
Description
Levels Of MCP-1
Timepoint
48 hours before and after intervention
Method of measurement
Blood sample
7
Description
Levels Of CRP protein
Timepoint
48 hours before and after intervention
Method of measurement
Blood sample
Secondary outcomes
1
Description
BMI
Timepoint
48 hours before and after intervention
Method of measurement
Using the weight squared height formula
Intervention groups
1
Description
Control group: People in this group had 16 weeks of daily life without participating in regular sports activities.
Category
Placebo
2
Description
Intervention group 1: Participants in this group consumed 5 grams of thylakoids dissolved in a glass of water 30 minutes before lunch without participating in exercise
Category
Treatment - Drugs
3
Description
Intervention group 2: People did HIFT exercise for 16 weeks in this group
Category
Treatment - Other
4
Description
Intervention group 3: The participants of this group received thylakoid supplements in addition to exercise. Packages containing thylakoid supplements were distributed among the participants in this group. In addition to exercise, the participants dissolved the contents of the bags containing the thylakoid supplement in a glass of water and consumed it 30 minutes before lunch
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The samples were selected through a call in administrative and public centers
Full name of responsible person
Heidar Ebadi asl
Street address
Shohaday Gomnam
City
Yazd
Province
Yazd
Postal code
8916713335
Phone
+98 35 3830 2188
Email
h.ebadi@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of scince and art
Full name of responsible person
Hamed Falah
Street address
Shohaday Gomnam
City
Yazd
Province
Yazd
Postal code
8916713335
Phone
+98 35 3820 2180
Email
fallah@sau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of scince and art
Proportion provided by this source
10
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
The University of Gilan
Full name of responsible person
Bahman Mirzaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Khalij fars
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
bahman.mirzaee@guilan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of guilan
Full name of responsible person
Bahman Mirzaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Khalij fars
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
bahman.mirzaee@guilan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of guilan
Full name of responsible person
Heidar Ebadiasl
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Shohaday gomnam
City
Yazd
Province
Yazd
Postal code
8916713335
Phone
0098 35 3802189
Email
h.ebadi@ut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
it will be made available after the articles are published
To whom data/document is available
Magazines and research institutes
Under which criteria data/document could be used
Reviewer and editor of magazines
From where data/document is obtainable
Gilan University, Faculty of Physical Education and Sports Sciences, Dr. Bahman Mirzaei
What processes are involved for a request to access data/document
In coordination with all researchers, it will be made available after the articles are published