The effects of two training program and vitamin D supplementation on lipid profile, leptin and body composition in obese adolescents with vitamin D deficiency
Comparison of the effect of two types of exercise programs and vitamin D supplementation on lipid profiles, leptin and body composition in obese adolescents with vitamin D deficiency.
Design
A single-blind randomized clinical trial in the form of pre-test-post-test with a control group in which 48 eligible male volunteers are selected and randomly divided into six groups of 8 people.
Settings and conduct
This study is carried out as a pre and post test in order to compare two methods of aerobic training with vitamin D supplementation on sedentary obese adolescents with vitamin D deficiency in Javanroud city. Eight weeks of training intervention with taking vitamin D supplement and placebo is done on subjects. This study is single-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being male; being at the age of 13-15 years old; Having an informed consent for participation in the study; 25-OHD serum levels less than 20 ng/ml; body mass index more than 30 kg/m2. Exclusion criteria: having regular exercise in past 3 months; having illness; taking drugs and supplements; drug and alcohol addiction.
Intervention groups
Intervention group 1:running on treadmill + vitamin D, eight weeks training and 2,000 IU/day of vitamin D3 supplementation; Intervention group 2:running on treadmill + placebo, eight weeks training and daily maltodextrin capsule; Intervention group 3:jump rope + vitamin D, eight weeks training and 2,000 IU/day of vitamin D3 supplementation; Intervention group 4:jump rope + placebo, eight weeks training and daily maltodextrin capsule; Intervention group 5: 2,000 IU/day of vitamin D3; Control group: has no activity and does not receive supplements or placebo.
Main outcome variables
Serum leptin level; body fat percentage; high density lipoprotein; low density lipoprotein; Triglyceride; total cholesterol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240702062312N1
Registration date:2024-07-31, 1403/05/10
Registration timing:prospective
Last update:2024-07-31, 1403/05/10
Update count:0
Registration date
2024-07-31, 1403/05/10
Registrant information
Name
Naser Rostamzadeh
Name of organization / entity
The University of farhangian
Country
Iran (Islamic Republic of)
Phone
+98 87 3371 1530
Email address
naserrostamzadeh806@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of two training program and vitamin D supplementation on lipid profile, leptin and body composition in obese adolescents with vitamin D deficiency
Public title
Leptin response to Training and Supplementation
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Being male
Being at the age of 13-15 years old
Body mass index (BMI) more than 30 kg/m2
Vitamin D deficiency (less than 20 ng/ml)
Exclusion criteria:
Doing regular exercise in the last 3 months
Any illness or acute discomfort
Lack of consent of parents or legal guardians
Having a medical prohibition to participate in physical activity
Taking medicine and supplements in the last 3 months
Drug and alcohol addiction
Age
From 13 years old to 15 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
A simple method of drawing a number randomly from a bag: The researcher assigns a number to each of the samples, then they are selected using the random number table model and randomly assigned to one of the groups. For this, a number will be defined for each of the samples and a number for each of the groups and will be placed in separate bags. The first number that is randomly selected from the bag of samples will be placed in the first group that is selected from the bag of groups, and this will continue until all the samples are placed in the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Groups that use vitamin D and placebo will use capsules with the same shape, taste, and color, and only the researcher knows which groups will use vitamin D and which groups will use placebo. The jump rope + vitamin D, running on treadmill + vitamin D and vitamin D groups will use 2000 IU of vitamin D in capsule form daily, and the jump rope + placebo and running on treadmill + placebo groups will use one placebo capsule daily in the same way.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Kurdistan
Street address
Pasdaran Blvd.,
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Approval date
2024-06-08, 1403/03/19
Ethics committee reference number
IR.UOK.REC.1403.022
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
Serum level of leptin
Timepoint
At the beginning of the study and 8 weeks after the start of the study
Method of measurement
Blood sampling
2
Description
Body fat percent
Timepoint
At the beginning of the study and 8 weeks after the start of the study
Method of measurement
Caliper
3
Description
High density lipoprotein (HDL)
Timepoint
At the beginning of the study and 8 weeks after the start of the study
Method of measurement
Blood sampling
4
Description
Low density lipoprotein (LDL)
Timepoint
At the beginning of the study and 8 weeks after the start of the study
Method of measurement
Blood sampling
5
Description
Triglyceride (TG)
Timepoint
At the beginning of the study and 8 weeks after the start of the study
Method of measurement
Blood sampling
6
Description
Total cholesterol (TC)
Timepoint
At the beginning of the study and 8 weeks after the start of the study
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 3 sessions per week, 3 × 10 min interval running at 70–85% HRmax separated by 5 min active recovery running on a treadmill, for 8 weeks with 2000 units per day vitamin D supplementation
Category
N/A
2
Description
Intervention group 2: 3 sessions per week, 3 × 10 min interval running at 70–85% HRmax separated by 5 min active recovery running on a treadmill, for 8 weeks with placebo
Category
Placebo
3
Description
Intervention group 3: 3 sessions per week, 30 min of exercise including 1 min of exercise with 30 seconds of rest at 60–90 jump/min jump rope for 8 weeks with 2000 units per day vitamin D supplementation
Category
N/A
4
Description
Intervention group 4: 3 sessions per week, 30 min of exercise including 1 min of exercise with 30 seconds of rest at 60–90 jump/min jump rope for 8 weeks with placebo
Category
Placebo
5
Description
Intervention group 5: Eight weeks of consumption of 2000 units per day vitamin D supplementation
Category
Treatment - Drugs
6
Description
Control group: Non intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Kurdistan
Full name of responsible person
Dariush Sheikholeslami Vatani
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
d.vatani@uok.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Ali Akbar Mozafari
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
a.mozafari@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 Kurdistan
Full name of responsible person
Dariush Sheikholeslami Vatani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
d.vatani@uok.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Kurdistan
Full name of responsible person
Dariush Sheikholeslami Vatani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
d.vatani@uok.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Farhangian
Full name of responsible person
Naser Rostamzadeh
Position
assistance of Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
No. 99, Azin5 Ave., Baharan Town
City
Sanandaj
Province
Kurdistan
Postal code
6617881554
Phone
+98 87 3371 1530
Email
naserrostamzadeh806@gmail.com
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
A part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research in this field
From where data/document is obtainable
naserrostamzadeh806@gmail.com
What processes are involved for a request to access data/document