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Effects of aerobic-resistance training combine with green coffee consumption on insulin-like growth factor-1 (IGF-1), leptin, testosterone, cortisol, insulin resistance, glucose homeostasis, heart rate, metabolism, body composition, physical fitness, general health, appetite, anxiety and depression in overweight and obese women

Protocol summary

Summary
The purpose of this study will be to evaluate the effect of aerobic-resistance training combine with green coffee consumption on Insulin-like growth factor-1, leptin, testosterone, cortisol, insulin resistance, glucose homeostasis, heart rate, metabolism, body composition, physical fitness, general health, appetite, anxiety and depression in overweight and obese women. Inclusion criteria consist of having age ranges 25 to 35 years old and not have metabolic or orthopedic disease and exclusion criteria will be consist of do not regular conduct of study interventions. In line with this, through overweight and obese women of Rasht city, 30 volunteers will be selected and randomly assigned into three groups and each group consist of 10 persons including: aerobic-resistance training, green coffee and aerobic- resistance training combine with green coffee. The study duration will be 6 weeks and green coffee and aerobic- resistance combine with green coffee groups will get 250 mg green coffee per day. Also, exercise program will be including of four sessions of aerobic- resistance training per week. Fasting blood sample will be taken 24 hour pre and post intervention for evaluating serum levels of IGF-1, leptin, testosterone, cortisol, insulin and fasting blood sugar.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061422498N13
Registration date: 2017-06-21, 1396/03/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of aerobic-resistance training combine with green coffee consumption on insulin-like growth factor-1 (IGF-1), leptin, testosterone, cortisol, insulin resistance, glucose homeostasis, heart rate, metabolism, body composition, physical fitness, general health, appetite, anxiety and depression in overweight and obese women
Public title
Effects of aerobic-resistance training combine with green coffee consumption in overweight and obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged of 25-35 years; not have regular exercise training during last year; not have metabolic or orthopedic disease Exclusion criteria: using weight loss supplements or drug over the last six month; have special diet; absence for more than three sessions of training; not regular usage of green coffee
Age
From 25 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Postal code
Approval date
2017-01-17, 1395/10/28
Ethics committee reference number
IR.IAU.RASHT.REC.1395.66

Health conditions studied

1

Description of health condition studied
Overweight and obese women
ICD-10 code
E66.0, E66
ICD-10 code description
Obesity due to excess calories, Obesity, unspecified

Primary outcomes

1

Description
Insulin-like growth factor-1 (IGF-1)
Timepoint
24 hour before and after interventions
Method of measurement
Serum levels using ELISA method (ng/ml)

2

Description
Leptin
Timepoint
24 hour before and after interventions
Method of measurement
serum levels using ELISA method (ng/ml)

3

Description
Testosterone
Timepoint
24 hour before and after interventions
Method of measurement
serum levels using photometric method (μg/dl)

4

Description
Cortisol
Timepoint
24 hour before and after interventions
Method of measurement
serum levels using ELISA method (μg/dl)

5

Description
Fasting blood suger
Timepoint
24 hour before and after interventions
Method of measurement
serum levels using photometric method (mg/dl)

6

Description
Insulin
Timepoint
24 hour before and after interventions
Method of measurement
serum levels using ELISA method (ρmol/L)

Secondary outcomes

1

Description
Insulin resistance
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using HOMA formula

2

Description
Heart rate
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using measurement of resting heart rate, systole and diastole blood pressure

3

Description
Basal and resting metabolic
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using BMR and RMR formula

4

Description
Body composition
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using measurement of weight, body mass index, body fat percent and waist to hip ratio

5

Description
Physical Fitness
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using measurement of aerobic power and anaerobic power

6

Description
General health
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using general health questionnaire

7

Description
Appetite
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using appetite questionnaire

8

Description
Anxiety and depression
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Using questionnaire

Intervention groups

1

Description
Aerobic- resistance training Four sessions per week, each session consist of 20-30 min aerobic training at 65-75 percent of maximum heart rate and fallowing that eight movement at 65-80 percent of one repetition maximum
Category
Prevention

2

Description
Green coffee Six weeks, two 125 mg serving per day, dissolving in hot water
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasht city, Advertising
Full name of responsible person
Sajedeh Movaghary
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Ali Delpasand
Street address
Islamic Azad University Rasht Branch, Taleshan Bredge, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Rasht Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Nafiseh Karimnezhad, Zivar Hasani, Afshin Saket
Position
MA
Other areas of specialty/work
Street address
Islamic Azad University Rasht Branch, Taleshan Bredge, Rasht
City
Rasht
Postal code
Phone
+98 13 3375 2715
Fax
Email
dr.ramin.shabani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Dr Ramin Shabani
Position
Associate Professor
Other areas of specialty/work
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Postal code
Phone
+98 13 3375 2715
Fax
Email
dr.ramin.shabani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Univercity Rasht Branch
Full name of responsible person
Fatemeh Izaddoust
Position
MA
Other areas of specialty/work
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Postal code
Phone
00
Fax
Email
fa.izaddoust@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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