Considering the anti-oxidant activity of Nigella Sativa by advising healthy people in order to reinforce antioxidant defending system can prevent disease (initial prevention) and in the patients also by reinforcing this system prevent the complications of disease or delay their appearance. With increasing the intensity of physical activity the oxidative stress, Lipid peroxidation and insufficiency of antioxidant defending system appears.
Design
Clinical trial having control group, has been randomized based on the community and pragmatic with parallel, two-way blind.
Settings and conduct
initially, the first blood sampling and after two months after the last exercise session and using tablet the last step blood sampling is performed. The assignment sequence is hidden by the envelopes encoded in the order numbered, and the letter envelops are opened only after the end of all initial and basic evaluations related to the participants.
Participants/Inclusion and exclusion criteria
statistical population of the study include 300 individuals with over weight by age range of 20 to 40 years old that are active in the gyms of Mashahad city. They are divided after matching based on the body mass index (25<BMI<30).
Intervention groups
Before the start of exercise program and use of supplement, during a briefing session, the specifications and history of disease of individuals are gathered by questionnaire of general health and their medical background. All volunteers will participate in a training program concerning the correct way of performing the exercises and how to use the supplement. Another objective of the course is training the reduction of subjects number through getting familiar with the exercise capacity of volunteers that may due to limitation/physical pain aren’t able to complete the exercise plan.
Main outcome variables
anti oxidant levels, obesity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040080N1
Registration date:2018-09-22, 1397/06/31
Registration timing:retrospective
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
malihe asiaban siuki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3272 1415
Email address
malihe_asiaban@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 8 weeks Resistance Band training with Nigella sativa seed supplementation on the Levels of antioxidant enzymes in overweight women
Public title
The effect of exercise and black seed on the levels of antioxidant enzymes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
BMI between 25 and 30
Exclusion criteria:
Menopause
Weight Loss
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants to research groups, a computational list of random numbers using a computer software (Random Allocation Software 2.0) is initially created by one of the research colleagues.
Then, the allocation of participants according to the body mass index varied in 4 groups using randomized block method. The limitation of this method is the prediction of final allocation, which is the solution of random use of blocks of different sizes.
Assignment sequences are hidden by the envelopes encoded in the order numbered, and the letter envelopes are opened only after all the initial and initial evaluations of the participants have been made.
Blinding (investigator's opinion)
Double blinded
Blinding description
Combination of the main black granular supplement with placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
دانشگاه علوم پزشکی شاهرود
Secondary trial Id
IR.SHMU.REC.1397.039
Registration date
2018-05-23, 1397/03/02
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrood Medical Sciences
Street address
Shahrood University of Medical Sciences
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.SHMU.REC.1397.039
Health conditions studied
1
Description of health condition studied
Overweight
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
antioxidants level
Timepoint
Initial blood collection and then the final blood sampling, after two hours after 48 hours after the last training session or supplementation.
Method of measurement
Measurements are made by the glutathione peroxidase and superoxide dismutase kits of America.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group had their daily activities and did not attend sports exercises and did not use any supplement. They are asked to stay in their diet until the end of the intervention period and not to change it.
Category
Placebo
2
Description
Intervention group 1: A daily black currant supplement group will take one 1000 mg capsule at a time, 30 minutes before meals.
Category
Treatment - Drugs
3
Description
Intervention group 2: Practice protocol 6 sessions per week for 8 weeks and each session for one hour (10 minutes of warming up 40 minutes, doing special exercises and 10 minutes of cooing) to practice, and after 8 weeks of post-test training.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Exercise gym in Mashhad
Full name of responsible person
Malihe Asiaban Siuki
Street address
No.1155, Between Tabarsi 55 and57Ave, Exercise gym
City
Mashhad
Province
Razavi Khorasan
Postal code
91489-16313
Phone
+98 51 3272 1415
Email
malihe_asiaabn@shahroodut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Shahrood
Full name of responsible person
Ali Hassani
Street address
University campus, Shahroud University
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
hassani_3@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Shahrood
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
The University of Shahrood
Full name of responsible person
Malihe Asiaban Siuki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
No.11,Meghdad 16.,Gaz sharghi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9148916313
Phone
+98 51 3272 1415
Email
malihe_asiaban@shahroodut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shahrood
Full name of responsible person
Malihe Asiaban Siuki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
No.11,Meghdad 16.,Gaz sharghi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9148916313
Phone
+98 51 3272 1415
Email
malihe_asiaban@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Shahrood
Full name of responsible person
Malihe Asiaban Siuki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
No.11,Meghdad 16.,Gaz sharghi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9148916313
Phone
+98 51 3272 1415
Email
malihe_asiaban@shahroodut.ac.ir
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