Protocol summary

Summary
The main purpose of this study is to investigate the effect of eight weeks elastic bands resistance training along with green coffee supplementation on lipid profiles and atherogenic index of plasma in obese women. Design and method of study: This study is an interventional and single blind research (related to the subjects of the study). 88 overweight female (aged 30-50 years, body mass index >30 kg/m2) are selected and randomly (based on random numbers table) will be divided into four groups of 22 participants: green coffee (GC), resistance band training with green coffee (RBT+GC), resistance band training (RBT) and control (C) groups. Subjects in green coffee supplementation group receive 400 mg capsules containing green coffee extract daily for 8 weeks. Elastic band training will be performed three sessions a week in an eight week period. The ten different exercises, three set for each exercise done. Inclusion criteria: female; age between 30 to 50 years old; obesity (BMI>30); green coffee insensitivity; the level of physical and mental health. Exclusion criteria: history of cardiovascular diseases; cancer; diabetes; kidney and liver disease; weight-loss dietary adherence; weight changes over 5 kg in the last three months; irregular menstrual cycle. Primary outcome: the lipid profiles and atherogenic index will be evaluated 24 hours before and 48 hours after training program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017090419995N9
Registration date: 2017-10-04, 1396/07/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-04, 1396/07/12
Registrant information
Name
Zahra Mardanpour Shahrekordi
Name of organization / entity
Shahrekord University
Country
Iran (Islamic Republic of)
Phone
+98 38 3232 4401
Email address
banitalebi@lit.sku.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-04-16, 1396/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks elastic bands resistance training along with green coffee supplementation on lipid profiles and atherogenic index of plasma in obese women
Public title
The effect of eight weeks resistance training along with green coffee supplementation in obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female; age between 30 to 50 years old; obesity (BMI>30); green coffee insensitivity; the level of physical and mental health. Exclusion criteria: history of cardiovascular diseases; cancer; diabetes; kidney and liver disease; weight-loss dietary adherence; weight changes over 5 kg in the last three months; irregular menstrual cycle.
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord university
Street address
Rahbar Blvd, Shahrekord
City
Shahrekord
Postal code
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
95/125

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Lipid profiles (TG, TC, HDL-C and LDL-C)
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Blood samples

2

Description
Atherogenic Index (AIP)
Timepoint
Before and after 8 weeks of intervention
Method of measurement
the logarithmic equation of TG to HDL-C ratio

Secondary outcomes

1

Description
Body fat percent
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Use the Harpenden model calipers

2

Description
Body Mass Index (BMI)
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Weight divided by height squared

3

Description
Weight
Timepoint
Before and after 8 weeks of intervention
Method of measurement
Weight meter

Intervention groups

1

Description
Intervention group 1: Subjects in green coffee supplementation group receive 400 mg capsules containing green coffee extract daily for 8 weeks.
Category
Treatment - Drugs

2

Description
Intervention group 2: Resistance band training with green coffee group, Subjects in this group in addition to received 400 mg capsules containing green coffee extract daily, elastic band training will be performed three sessions a week in an eight week period.
Category
Other

3

Description
Intervention group 3: Resistance band training group, in this group will be performed elastic band training three sessions a week in eight week. In each session of Resistance band training are performed 10 exercises in 3 cycles for each exercise.
Category
Other

4

Description
Control group: The control group consume one daily capsule containing roasted wheat flour with the same appearance as the original supplement (as placebo).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali medical clinic
Full name of responsible person
Dr Tina Jafari
Street address
Emam Ali medical clinic, Shariaati street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University
Full name of responsible person
Dr Mohammad Faramarzi
Street address
Vice Chancellor for research, Shahrekord University, Rahbar Blvd, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord University
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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Tina Jafari
Position
Assistant Professor, School of Medicine
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 4911
Fax
Email
Tinajafari15@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Dr Mohammad Faramarzi
Position
Associate Professor, PhD in Exercise Physiology
Other areas of specialty/work
Street address
Rahbar Blvd, Shahrekord
City
shahrekord
Postal code
Phone
+98 38 3232 4401
Fax
Email
md.faramarzi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Dr Ebrahim Banitalebi
Position
Assistant Professor, PhD in Exercise Physiology
Other areas of specialty/work
Street address
Rahbar Blvd, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3232 4401
Fax
Email
Web page address

Sharing plan

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