The effects of jump rope interval training and dark chocolate on serum levels of some inflammatory adipokines and cytokines in adolescent males with obesity
The aim of this study is to investigate the effects of dark chocolate supplementation and rope jump interval training on serum levels of some inflammatory adipokines and cytokines in adolescent males with obesity.
Design
Study design: Randomized double-blinded controlled clinical trial. Blinding is carried out for subjects and researchers and randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block. Population and sample size: 48 sedentary adolescent males with obesity who are not participated in any regular training program for at least 6 months before the study.
Settings and conduct
This study will be conducted at Astan Qods Razavi Sports Complex. 48 sedentary adolescent males with obesity will be randomized to 4 groups: 1) interval training + placebo; 2) dark chocolate; 3) interval training + dark chocolate; and 4) Control. blinding will be done for interventions for both researchers and participants. randomization will done using quadratic block.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adolescent males with obesity aged 13 to 17 years without participating in any regular training program Exclusion criteria: recent infections, joint and bone injuries, and symptoms of metabolic disease.
Intervention groups
Intervention 1: received 30 grams dark chocolate per day, for six weeks Intervention 2: exercise training including rope jump interval training, 5 times/wk Intervention 3: received one capsule containing chickpea flour, for six weeks
The effects of jump rope interval training and dark chocolate on serum levels of some inflammatory adipokines and cytokines in adolescent males with obesity
Public title
The effects of jump rope interval training and dark chocolate on serum levels of some inflammatory adipokines and cytokines
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
BMI=28.22 or more
Without any metabolic disease
No smoking
No alcoholism
Not taking supplements (including vitamins, minerals, ergogenic aids) and medication for at least 2 months before the study
Not participating in any regular training program for at least 6 months before the study
Interesting in participation in research
Age of 13-17
Exclusion criteria:
Use of immune system suppressor drugs 6 mounts before research
Recent infections
Joint and bone injuries
Metabolic disease
No interesting for participation
Age
From 13 years old to 17 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding will be done for interventions for both researchers and participants. The chocolates and capsules will be given in the same bottle and will be coded for each groups by someone who are not enroll in the study design .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sports Sciences Research Institute
Intervention group: received 30 grams dark chocolate per day, for six weeks
Category
Lifestyle
2
Description
Intervention group: exercise training including rope jump interval training, 5 times/wk, for six weeks
Category
Lifestyle
3
Description
Control group: received one capsule containing chickpea flour, for six weeks
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Private
Full name of responsible person
Babak Hooshmand Hoghadam
Street address
Ferdowsi Blvd, Astan Qods Razavi Sports Complex
City
Mashhad
Province
Razavi Khorasan
Postal code
9177935176
Phone
+98 51 3881 0540
Email
b.hooshmand.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sports Sciences Research Institute
Full name of responsible person
Babak Hooshmand Hoghadam
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417466191
Phone
+98 51 3881 0540
Email
b.hooshmand.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sports Sciences Research Institute
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Reza Bagheri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Isfahan, Azadi square, University of Isfahan
City
Isfahan
Province
Razavi Khorasan
Postal code
8174673441
Phone
+98 51 3521 4043
Email
will.fivb@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Damoon Ashtary-Larky
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3443 6106
Email
Damoon_ashtary@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Reza Bagheri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Isfahan, Azadi square, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 51 3521 4043
Email
will.fivb@yahoo.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
Publication of protocol study in form of the article and also data publication in the original article. The total potential data can be shared after unidentifiable subjects.
When the data will become available and for how long
6 months after the publication of results
To whom data/document is available
All researchers who have access to clinical trials databases.
Under which criteria data/document could be used
The only way for using the data is after the publication of the article in the indexed ISI journal.
From where data/document is obtainable
Via database websites such as PubMed and google scholar and via email address: damoon_ashtary@yahoo.com
What processes are involved for a request to access data/document
The original article reaches the requestor by email within a maximum of one week.