Evaluation of weight and appetite changes caused by regular exercise and vitamin D supplementation
Design
The present study is a randomized clinical trial and the subjects are assigned in the pretest-posttest design with the control group. Subjects randomly are divided into four groups including: training group with vitamin D supplementation (n=12), training group with placebo(n=12),supplementation group(n=12) and control group(n=12).experimental groups were given 3 sessions per week during 8 weeks .
Settings and conduct
This study is the semi- experimental and double-blind (neither the researcher nor participants are aware of which placebo or supplement group they receive) will be conducted in the Javanroud. The experimental group will perform training in Imam Khomeini cloub and blood sampling from each of the two groups will perform in the Hazrat Rasoul hospital laboratories in Javanrud.
Participants/Inclusion and exclusion criteria
Inclusion criteria:14>Age>30;Over weight (a body mass index above 25kg/m2);Having an informed consent for participation in the study
Non-inclusion criteria: Gender(Women); having desaese and taking drugs and supplements; drug and alcohol addiction; having regular exercise in recent 6 months
Intervention groups
Intervention group1: were given 3 sessions per week (85 to 95% max heart rate) during 8 weeks
Intervention group2: In addition to given 3 sessions per week ( 85 to 95% ax heart rate) during 8 weeks,take daily 2000 IU of vitamin D3 supplementation .
Intervention group3:Only take daily 2000 IU of vitamin D3 supplementation.
Control group:The control will have no supplement and regular exercise program during this time and will only participate in pre-test and post-test measurements.
Main outcome variables
Weight; BMI; appetite related hormones change includs: Acylated Ghrelin; PYY; Orexin and Insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180708040392N2
Registration date:2019-09-13, 1398/06/22
Registration timing:prospective
Last update:2019-09-13, 1398/06/22
Update count:0
Registration date
2019-09-13, 1398/06/22
Registrant information
Name
Naser Rostamzadeh
Name of organization / entity
The University of Kurdestan
Country
Iran (Islamic Republic of)
Phone
+98 87 3371 1530
Email address
n.rostamzadeh@hum.uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks interval training with vitamin D supplementation on appetite –depended hormones in overweight men
Public title
The effect of interval training with vitamin D supplementation on appetite –depended hormones
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 14-30 years old
BMI>25 kg/m2
Informed concent
Exclusion criteria:
Gender (Women can not be selected as a sample)
People who have a certain disease and take medication
Having a regular sports activity during recent 6 months
Having drug and smoking addiction
Age
From 14 years old to 30 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by simple drawing method:The researcher devote a number to each of the samples, then they are being selected by using the random number table or the computer model and randomly assigned to one of the groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Both participants and the researcher were kept blind in this study
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University
Street address
Kurdistan University , Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۷۷-۱۵۱۷۵
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.UOK.REC.1398.024
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Obesity
Timepoint
Before starting the protocol and again after 8 weeks training
Method of measurement
Measure of Body Mass Index ( BMI )
2
Description
Accylated Ghrelin
Timepoint
Before starting the protocol and again after 8 weeks training
Method of measurement
Serum ELISA Kit
3
Description
PYY
Timepoint
Before starting the protocol and again after 8 weeks training
Method of measurement
Serum ELISA Kit
4
Description
Orexin
Timepoint
Before starting the protocol and again after 8 weeks training
Method of measurement
Serum ELISA Kit
5
Description
Insulin
Timepoint
Before starting the protocol and again after 8 weeks training
Method of measurement
Serum ELISA Kit
Secondary outcomes
1
Description
The amount of calorie intake
Timepoint
before starting the intervention and after a 8 weeks training
Method of measurement
By remember food intake form
Intervention groups
1
Description
Intervention group: do interval training for 8 weeks and taken 2000 IU of vitamin D3 supplement per day
Category
Lifestyle
2
Description
Control group: This group does not receive any intervention and only participates in measurements
Category
Lifestyle
3
Description
Intervention group: do interval training for 8 weeks and taken placebo per day
Category
Placebo
4
Description
Intervention group: taken 2000 IU vitamin D per day
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Kurdistan
Full name of responsible person
Naser Rostamzadeh
Street address
No.1, Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Mehrdad Khamforoush
Street address
University of Kurdistan, Pasdaran, Sanandaj
City
Sansndaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
m.khamforoush@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kurdistan
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 Kurdestan
Full name of responsible person
Naser Rostamzadeh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
No.1,Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Kurdestan
Full name of responsible person
Naser Rostamzadeh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
No.1, Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Naser Rostamzadeh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
No. 1, Zibashahr Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617883357
Phone
+98 87 3371 1530
Email
n.rostamzadeh@hum.uok.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as average age, gender, the average of the body mass index and results of the outcome have the possibility of sharing
When the data will become available and for how long
6 months after the report of results
To whom data/document is available
Researchers in Academic and scientific institutions
Under which criteria data/document could be used
Only for compare with similar research using the documentation permitted
From where data/document is obtainable
By email
What processes are involved for a request to access data/document
After sending the request via e-mail, lasts for 2 months