Effect of eight weeks of aerobic training with and without green coffee consumption on lymphocyte ABCG1 Gene Expression, Apo-B100 and some of the Cardiovascular risk factor in 30 non-Athlete and overweight women
The effect of eight weeks of aerobic training and green coffee consumption on ABCG1, Apo-B100 gene expression and some cardiovascular risk factors in overweight non-athletic women.
Design
A randomized, single-blind, placebo-controlled clinical trial
Settings and conduct
During the call at the Shahid Beheshti Club in Mashhad, 30 participants were randomly selected and randomly divided into two groups of green coffee consumption and placebo consumption And they were told that all the capsules were green coffee.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 35 to 45 years with overweight and BMI ranging from 25 to 29.9 kg / m2 and not trained. Be physically and mentally healthy and not at all menopausal. During the three days before and after the menstrual cycle, they took no medication at all. They have not used dietary, nutritional, and dietary supplements since two months ago. Do not have a special diet. They did not smoke, and were also obliged to attend meetings and observe conditions set by researchers and educators from beginning to end.
Exclusion criteria: Non-compliance, Going on a trip, Non-compliance with diet and Illness and absence at training sessions
Intervention groups
Exercise group with green coffee intake: start aerobic exercise at 40% intensity (maximum heart rate) / 30 min / three sessions per week and increase to 60 min / 70% intensity / three sessions per week.
Aerobic exercise group with placebo: similar to group 1
Main outcome variables
ABCG1 gene; ApoB100; HDL; LDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191227045907N1
Registration date:2020-01-22, 1398/11/02
Registration timing:retrospective
Last update:2020-01-22, 1398/11/02
Update count:0
Registration date
2020-01-22, 1398/11/02
Registrant information
Name
Ahmad Shajiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3833 6796
Email address
ahmad.shajie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2018-12-31, 1397/10/10
Trial completion date
2020-03-05, 1398/12/15
Scientific title
Effect of eight weeks of aerobic training with and without green coffee consumption on lymphocyte ABCG1 Gene Expression, Apo-B100 and some of the Cardiovascular risk factor in 30 non-Athlete and overweight women
Public title
Effect of aerobic training and green coffee consumption in overweight women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
BMI range between 25 and 29.9 kg / m2
non-athlete
Have physical and mental health
No disease
Do not be menopausal
Be in the three days before and after menstruation
Do not take any medication
They have not used nutritional and nutritional supplements since two months ago
Do not have a special diet
No smoking
If they wish to participate in the research, they are obliged to comply with the conditions set forth from beginning to end.
Age range between 35-45 years
Exclusion criteria:
Non-compliance
Disease
Having a diet
taking medication
Being in the menstrual cycle
Taking nutritional supplements
Go to travel
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Note the total names of participants on paper in a container, then randomly withdrawing 30 individuals as sample size from the container containing the names, and then randomly divided into two groups of 15 individuals each with aerobic exercise with and without green coffee.
Blinding (investigator's opinion)
Single blinded
Blinding description
The green coffee capsules were given to the exercise group with the green coffee and the placebo capsules containing wheat flour to the placebo exercise group. The capsules were similar in appearance, odor, color and taste, and only the subjects were not aware of the contents of the capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Neyshabour Branch
Street address
Islamic Azad University, Neyshabur Branch, Imam Mohammad Ghazali Boulevard, Neyshabur
City
MASHHAD
Province
Razavi Khorasan
Postal code
۹۳۱۹۷۹۷۱۳۹
Approval date
2018-12-13, 1397/09/22
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1397.018
Health conditions studied
1
Description of health condition studied
ABCG1 gene
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ATP-binding cassette Transport G1 gen
Timepoint
48 hours before and 48 hours after the first and last aerobic training session
Method of measurement
Centrifuge and isolate lymphocytes and then investigate gene expression by RT-PCR method
2
Description
Apolipoprotein B100
Timepoint
48 hours before and 48 hours after the first and last aerobic training session
Method of measurement
5 cc of blood sample and ELISA method
3
Description
High-density lipoprotein
Timepoint
48 hours before and 48 hours after the first and last aerobic training session
Method of measurement
Spectrophotometry method
4
Description
Low-density lipoprotein
Timepoint
48 hours before and 48 hours after the first and last aerobic training session
Method of measurement
Spectrophotometry method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aerobic exercise with green coffee intake: 40-70% MHR / three sessions per week / 30-60 minutes per session. 400 mg capsules daily one hour before exercise
Category
Prevention
2
Description
Intervention group: Aerobic exercise with green coffee intake: 40-70% MHR / three sessions per week / 30-60 minutes per session. placebo capsules daily one hour before exercise
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Beheshti Club of Mashhad
Full name of responsible person
Ahmad Shajie
Street address
Mashhad Ferdowsi Boulevard Shahid Beheshti Club
City
MASHHAD
Province
Razavi Khorasan
Postal code
918587720
Phone
+98 51 3768 3010
Email
info@cfu.ac.ir
Web page address
https://pbm.cfu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Zendedel
Street address
Neyshabour, Research Street, Islamic Azad University, Neyshabour Branch Complex
City
Neyshabour
Province
Razavi Khorasan
Postal code
۹۳۱۹۷۹۷۱۳۹
Phone
+98 51 4262 1901
Email
pajohesh@iau-neyshabur.ac.ir
Web page address
http://iau-neyshabur.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
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
Ferdowsi University of Mashhad
Full name of responsible person
Amir Rashidlamir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Ferdowsi University of Mashhad, Faculty of Sport Sciences
City
MASHHAD
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
pr@um.ac.ir
Web page address
https://www.um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Amir Rashidlamir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
Mashhad Ferdowsi University of Mashhad Faculty of Sport Sciences
City
MASHHAD
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
pr@um.acir
Web page address
https://www.um.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Ferdowsi University of Mashhad
Full name of responsible person
Amir Rashidlamir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
Mashhad Ferdowsi University of Mashhad Faculty of Sport Sciences
City
MASHHAD
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
amir.rashidlamir@gmail.com
Web page address
https://www.um.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of eight weeks of aerobic exercise and green coffee consumption on ABCG1 lymphocyte, Apo-B100 gene expression and LDL / HDL and CT / HDL ratio in overweight non-athletic women
When the data will become available and for how long
Two months after printing the results
To whom data/document is available
Researchers and anyone you know in the field of science
Under which criteria data/document could be used
Protecting Data Security - Use in scientific and research areas
From where data/document is obtainable
Amir Rashidlamir- 09151514174- Ferdowsi University of Mashhad School of Sport Sciences - amir.rashidlamir@gmail.com
Ahmad Shajie- 09155048659- Neyshabour Azad University School of Sport Sciences- ahmad.shajie@gmail.com
What processes are involved for a request to access data/document
Two Months After Publishing in Scientific Research Journals