Protocol summary

Study aim
Assessing the effects of eight weeks concurrent training combine with Chamomile consumption on the level of glucose homeostasis, anxiety, depression, general health, body composition and physical activity in overweight and obese women
Design
Randomized clinical trail, with parallel groups
Settings and conduct
Among the women’s of Khomam city, 30 overweight and obese women will be select and randomly divide in to three equal groups including concurrent training group, concurrent training combine with Chamomile consumption and control groups. concurrent aerobic-resistance training will be conducting three time per week and Chamomile will be consuming on a daily basis. The study duration will be eight weeks. The level of glucose homeostasis, anxiety, depression, general health, body composition and physical activity will be measuring before and after the end of interventions period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: be woman; age ranges of 20-45 years old; have overweight or obese; be active; not have metabolic or orthopedic disorders Exclusion criteria: have allergy to chamomile; not regular consumption of chamomile; more than three session absence from the training
Intervention groups
Concurrent training group: eight weeks, three times per week, each session 60-90 min (including warm up, aerobic interval training, resistance training and cool down) Concurrent training combine with Chamomile consumption group: eight weeks, three time concurrent training per week (similar to concurrent training group) combine with daily consumption of 1.5 g Chamomile (before three main meal) Control group: no intervention
Main outcome variables
Glucose homeostasis; Anxiety, Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150531022498N11
Registration date: 2018-01-21, 1396/11/01
Registration timing: retrospective

Last update: 2018-01-21, 1396/11/01
Update count: 0
Registration date
2018-01-21, 1396/11/01
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
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2017-10-06, 1396/07/14
Actual recruitment end date
2017-10-22, 1396/07/30
Trial completion date
empty
Scientific title
Effects of concurrent training combine with Chamomile consumption on glucose homeostasis, anxiety, depression, general health, body composition and physical fitness in overweight and obese women
Public title
Effects of concurrent training combine with Chamomile consumption in overweight and obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
be woman age ranges of 20-45 years old have overweight or obese be active not have metabolic or orthopedic disorders
Exclusion criteria:
have allergy to chamomile not regular consumption of chamomile more than three session absence from the training
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning samples using simple random-lottery method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Approval date
2017-09-18, 1396/06/27
Ethics committee reference number
IR.IAU.RASHT.REC.1396.103

Health conditions studied

1

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

Primary outcomes

1

Description
Glucose homeostasis
Timepoint
Before and 24 hour after the interventions period
Method of measurement
Measuring fasting blood glucose, insulin and HOMA

2

Description
Anxiety
Timepoint
Before and after the end of interventions
Method of measurement
Using beck questionnaire

3

Description
Depression
Timepoint
Before and after the end of interventions
Method of measurement
Using beck questionnaire

Secondary outcomes

1

Description
General health
Timepoint
Before and after the end of interventions
Method of measurement
Using questionnaire

2

Description
Body composition
Timepoint
Before and after the end of interventions
Method of measurement
Using body mass index, waist to hip ratio, fat percent and fat free mass

3

Description
Physical fitness
Timepoint
Before and after the end of interventions
Method of measurement
Measuring muscle endurance and maximum oxygen consumption

Intervention groups

1

Description
Concurrent training group: eight weeks, three times per week, each session consist of 60-90 min (including warm up, aerobic interval training, resistance training and cool down)
Category
Prevention

2

Description
Concurrent training combine with Chamomile consumption: eight weeks, three time concurrent training per week (Similar to concurrent training group) combine with daily consumption of 1.5 g Chamomile (before three main meal)
Category
Prevention

3

Description
Control group: no intervention will be conducting.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khomam city
Full name of responsible person
Hadis Heidary
Street address
Khomam, Guilan, Iran
City
Khomam
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Islamic Azad University Rasht Branch, Taleshan Bredge
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personality, Researcher
Proportion provided by this source
100
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hadis Heidary
Position
MA student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin Shabani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3375 2715
Email
dr.ramin.shabani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Izaddoust
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4186886987
Phone
+98 13 3385 6174
Email
fa.izaddoust@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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