Protocol summary

Study aim
Effect of Eight weeks of metabolic resistance training and green coffee consumption on the expression of bone morphogenic proteins and the expression of nonplacental proteins and serum high-density lipoprotein in overweight women.
Design
A clinical trial with a control group without blinding and with block randomization. Randomization was done in two levels to determine the intervention of exercise and the intervention of supplement.
Settings and conduct
During the study, female candidates for the test will refer to Walia Elah Clinic in Tehran, and if they are eligible, they will be included in the study and will be randomly assigned to the intervention and control groups using the random block method. Blinding was not done in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Body Mass Index (BMI) less than 28 and more than 25, being physically active, not taking medicine or supplements, Respiratory health, Having a Covid 19 vaccine card. Exclusion criteria: pregnancy, menopause, and addiction to alcohol or tobacco.
Intervention groups
Intervention group 1: 400 mg green coffee supplement by Sahle company three times a day for two months; Intervention group 2: Metabolic Resistance Training three days a week for 45 minutes for eight weeks; Intervention group 3: 400 mg green coffee supplement along with Training three days a week for 45 minutes during eight weeks; Control group: Without training and taking green coffee supplements
Main outcome variables
Expression of bone morphogenic proteins (2 4 6 7 ) and uncoupled proteins and serum high density lipoprotein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200511047401N2
Registration date: 2022-08-29, 1401/06/07
Registration timing: retrospective

Last update: 2022-08-29, 1401/06/07
Update count: 0
Registration date
2022-08-29, 1401/06/07
Registrant information
Name
Maryam Takhty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7760 5721
Email address
maryam.takhty@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
2022-01-05, 1400/10/15
Actual recruitment end date
2022-01-06, 1400/10/16
Trial completion date
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Scientific title
Eight weeks of MRT (Metabolic Resistance Training) and CGA (Colorogenic Acid) consumption on BMP 2, 4, 6, 7 (Bones Morphogenic Proteins) and Ucp1 (Un Coupling Protein 1) protein expression and HDL ( High density Lipoprotein) in overweight women
Public title
MRT training and CGA consumption on BMP 2, 4, 6, 7 protein expression and Ucp1 and HdL expression in overweight women
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
The body mass index of the women participating in the study should be more than 25 and less than 28 Participating people must have been physically active for the past six months with the aim of maintaining health Not taking supplements that affect the variables under study, not using any medicine that could challenge the study process Respiratory health Having a Covid 19 vaccine card
Exclusion criteria:
Postmenopausal and pregnant women Alcoholism and smoking
Age
From 30 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used. Randomization will be done in two levels to determine the exercise intervention and then to determine the intervention of the supplement. First, using the letters A (intervention) and B (no-intervention), 6 blocks of 4 are created. Each letter must be repeated twice in each block (example: AABB). Each of the created blocks is given a number from 1 to 6 and then one of the blocks of 4 is selected using a dice. The dice will be thrown a total of ten times to determine the status of all participants in the study. The order of the letters in the selected block will indicate the status of training intervention for the people participating in the study. Each time the dice is thrown, the status of the training intervention will be determined for 4 consecutive people participating in the study. After the end of this phase, the people participating in the study will be divided into two groups of 20, including the training intervention group and the control group. Then again, the block randomization method will be used according to the previous steps to determine the type of supplement intervention. This stage will be done separately for people in the supplement intervention and no-intervention groups. At this stage, the letter A will indicate receiving nutritional supplements and B will indicate no intervention. Finally, after the completion of this stage, there will be 40 double combinations of letters A and B (with the possibility of repetition), and these combinations will be numbered from 1 to 40, and each number will have a random 8-digit code of a combination of letters and numbers. The determined combinations are written on paper and placed in a closed envelope. Then the code related to them is written on the envelope and all envelopes are given to the research team. After the first person enters the study, the code of the envelope (8-digit code) is announced to the group of researchers and they are asked to assign the person to one of the four groups according to the letters inside the envelope (the first letter indicates the status of training intervention and the second one indicates the status of nutritional supplement intervention, for example, a person with AB envelope will be assigned to the training intervention group and no- intervention supplement group). This process will continue until the arrival of the 40th person, and the research team will not be aware of the allocation status of the next patient and the envelope associated with the next patient during sampling.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Research Institute of Physical Education and Sports Sciences
Street address
No. 3, 5thAlley,Miremad Ave. , Motahary St
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.SSRC.REC.1401.037

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
The expression of bone morphogenic protein2
Timepoint
At the beginning of the study, 24 hours before the start of the study, 8 am fasting, and after two months, after the last training session and consumption of green coffee, 24 hours later, at 8 am fasting
Method of measurement
ELISA test will be used to check the expression level of bone morphogenic proteins 2

2

Description
The expression of uncoupled proteins1
Timepoint
At the beginning of the study, 24 hours before the start of the study, 8 am fasting, and after two months, after the last training session and consumption of green coffee, 24 hours later, at 8 am fasting
Method of measurement
Measuring the expression of uncoupled proteins was done using the mRNA extraction method and for calculating the expression of the genes, real time PCR test will be used

3

Description
Serum high density lipoprotein
Timepoint
At the beginning of the study, 24 hours before the start of the study, 8 am fasting, and after two months, after the last training session and consumption of green coffee, 24 hours later, at 8 am fasting
Method of measurement
Hitachi biochemistry autoanalyzer will be used to measure the fat profile of the subjects. High-density lipoprotein measurement will be done using Pars Azmoun kit and photometric method

4

Description
The expression of bone morphogenic protein4
Timepoint
At the beginning of the study, 24 hours before the start of the study, 8 am fasting, and after two months, after the last training session and consumption of green coffee, 24 hours later, at 8 am fasting
Method of measurement
ELISA test will be used to check the expression level of bone morphogenic proteins 4

5

Description
The expression of bone morphogenic protein6
Timepoint
At the beginning of the study, 24 hours before the start of the study, 8 am fasting, and after two months, after the last training session and consumption of green coffee, 24 hours later, at 8 am fasting
Method of measurement
ELISA test will be used to check the expression level of bone morphogenic proteins 6

6

Description
The expression of bone morphogenic protein 7
Timepoint
At the beginning of the study, 24 hours before the start of the study, 8 am fasting, and after two months, after the last training session and consumption of green coffee, 24 hours later, at 8 am fasting
Method of measurement
ELISA test will be used to check the expression level of bone morphogenic proteins 7

Secondary outcomes

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Intervention groups

1

Description
The first intervention group: exercise training includes metabolic resistance exercises that are performed three days a week for 45 minutes for 8 weeks with an intensity of 65 to 75% of the heart rate
Category
Lifestyle

2

Description
The second intervention group: 400 mg of green coffee of Sahle Co. supplement consumed daily for two months before main meals
Category
Lifestyle

3

Description
The third intervention group: training and supplement , includes metabolic resistance training, three days a week for 45 minutes in 8 weeks with an intensity of 65 to 75% heart rate accompanied by consumption of 400 mg green coffee of Sahle Co. for two months before the main meals daily .
Category
Lifestyle

4

Description
Control group: Did not receive any green coffee supplements and did not have metabolic resistance exercise
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Waliullah Clinic
Full name of responsible person
Farank Naeej
Street address
No.312, West Mahalati Ave.
City
Tehran
Province
Tehran
Postal code
1175875561
Phone
+98 21 3313 2114
Email
valiollah.kheyreah@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Babak Mozafari
Street address
Islamic Azad University Science and Research , University Square Branch.,Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5686
Email
basic‑fa@srbiau.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
Maryam Takhty
Position
Phd. Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No.14 Nikoo Ghadam Ave,. Sohravardi Blvd.
City
Tehran
Province
Tehran
Postal code
1551816717
Phone
+98 21 8604 7182
Email
Takhty.ma@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Takhty
Position
phd Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
4th floor.,No. 14 ,Nikoghadam Ave.,North Sohrevardi Blvd.
City
Tehran
Province
Tehran
Postal code
1551816717
Phone
+98 21 8604 7182
Email
Takhty.ma@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Takhty
Position
phd Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
4th flor.,No.14., Nikoo Ghadsm Ave., Sohravardi Blvd.
City
Tehran
Province
Tehran
Postal code
1551816718
Phone
+98 21 8604 7182
Email
Takhty.ma@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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