The effect of of High intensity training (HIT) and consumption of Echium amoenum on levels of reactive protein C and ferritin in overweight and obese women.
Design
controlled clinical trial with a parallel group design of 40 Subjects, Randomised
Settings and conduct
The study was conducted in one of the clubs in Isfahan. After initial assessments, 40 individuals were purposively selected as sample. After signing written consent by participants and measuring body composition Subjects were randomly divided into four groups of High intensity training (HIT) , high-intensity exercise and Echium amoenum, Echium amoenum and control groups. Blood samples were collected and analyzed before and after 12 weeks to measure serum C-Reactive Protein (CRP) and ferritin levels.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Age range of 30 to 35 years , BMI> 25
Exclusion criteria: Participate in exercise training for at least the past six months, developing structural and abnormal diseases, developing cardiovascular disease
Intervention groups
Intervention group 1 : Interval Training :High intensity training program was performed three sessions per week for 12 weeks. The exercise program consisted of four four-minute intervals of 85 to 90 percent of maximum heart rate .
Intervention group 2 : Echium amoenum consumption : Participants received four grams of Echium amoenum daily in 250 ml of boiling water for 10 minutes, infused daily for 12 weeks.TheEchium amoenum was obtained from Isfahan Shad Company.
Intervention group 3 : Interval training and Echium amoenum consumption : Interval Training Intervention group and Echium amoenum
Control group: No intervention
Main outcome variables
serum C-Reactive Protein (CRP), Ferritin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170510033909N6
Registration date:2019-09-12, 1398/06/21
Registration timing:retrospective
Last update:2019-09-12, 1398/06/21
Update count:0
Registration date
2019-09-12, 1398/06/21
Registrant information
Name
فرزانه تقیان
Name of organization / entity
دانشگاه آزاد اسلامی.واحد اصفهان
Country
Iran (Islamic Republic of)
Phone
+98 913 308 0241
Email address
f.taghian@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 12 weeks HIT training and Echium amoenum on Ferritin and CRP levels in obese women
Public title
Investigating the effect of exercise and Echium amoenum on reducing obesity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 30 to 35 years
BMI> 25
Exclusion criteria:
Take an intervention to lose weight in the last year
participation in athletic exercises for at least the last six months
Structural Disease
History of fractures in the last 1 year
cardiovascular, renal, hormonal and liver disease
Menopause
History of surgery in the last 1 year
Age
From 30 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization;
Randomization Tool: Random Number Table;
Randomization Unit: Individual;
In order to use the random number table, the researcher first determined the reading side of the table numbers.
The numbers were then assigned to different groups. For example, zero to twenty-four for intervention A, twenty-five to forty-nine for intervention B, fifty to seventy-four for group C, and seventy-five to nine for group D.
Then we place one of the numbers and move in one of the predetermined directions. The numbers were recorded and assigned to the four target groups, the HIT training group, the Echium amoenum group , the combination group, and the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
(Ethics Committee on Research Islamic Azad University - Isfahan Branch (Khorasgan
Street address
University Blvd , Arghavanie , East Gay Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.100
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
CRP
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Serum concentration of CRP by ELISA method using the Lake.Inc Monobind USA.C kit in USA
Secondary outcomes
1
Description
Ferritin
Timepoint
At the beginning and end of the study after 8 weeks
Method of measurement
Ferritin was measured using a Swiss-made Roche kit with a Cobas E4110 device by electrochemical luminescence (Ecl).
Intervention groups
1
Description
Intervention group 1: Interval Training :High intensity training program (95-85% of maximum heart rate) was performed three sessions per week for 12 weeks.The exercise program consisted of four four-minute intervals of 85 to 90 percent of maximum heart rate in the first six weeks and 90 to 95 percent of maximum heart rate in the second six weeks of three-minute active rest periods of 50-60% of maximal heart rate was administered. Also 15 minutes of cooling with 50-60% of maximum heart rate was performed at the end of each training session.
Category
Treatment - Other
2
Description
Intervention group 2: Echium amoenum consumption : Participants received four grams of Echium amoenum daily in 250 ml of boiling water for 10 minutes, infused daily for 12 weeks.TheEchium amoenum was obtained from Isfahan Shad Company.
Category
Treatment - Other
3
Description
Intervention group 3 : Interval training and Echium amoenum consumption: Interval Training Intervention group :High intensity training program (95-85% of maximum heart rate) was performed three sessions per week for 12 weeks. The exercise program consisted of four four-minute intervals of 85 to 90 percent of maximum heart rate in the first six weeks and 90 to 95 percent of maximum heart rate in the second six weeks of three-minute active rest periods of 50-60% of maximal heart rate was administered. Also 15 minutes of cooling with 50-60% of maximum heart rate was performed at the end of each training session.Participants received four grams of Echium amoenum daily in 250 ml of boiling water for 10 minutes, infused daily for 12 weeks. The Echium amoenum was obtained from Isfahan Shad Company.
Category
Treatment - Other
4
Description
Control group: No intervention, only follow up
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Diet Therapy , Isfahan Clinic Hospital
Full name of responsible person
Hajar Bahador
Street address
Isfahan Hospital ,Ordibehesht Ave SheikhBahaei St
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31 3233 0018
Email
H.bahador52231@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
Full name of responsible person
Majid Toghyani
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
Toghiani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
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
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
F_taghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
The University of Khorasgan, Isfahan
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31335002352
Email
F_taghian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University , Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2352
Fax
Email
F_taghian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD