Protocol summary

Study aim
The aim of this study is to survey the metabolic response to a single bout of high intensity interval and/or functional exercise in fasting and feeding.
Design
Randomised parallel clinical trial with control group, not blinded
Settings and conduct
Trial location: Faculty of physical education, University of Guilan Subjects will be asked to complete a 72 h food record before the trail session and avoid to consume caffeine. In the test day, fed groups will have the regular breakfast and others will stay fasted. 1 h later the participate even in HIIT or Crossfit exercise or nothing. Both protocol lasts 53 min and OMNI scale will be used for the intensity assessment. Right after the session completion, blood samples will be collected and transferred to the lab for analysis.
Participants/Inclusion and exclusion criteria
Female physical education students who are dorm resident, 17-20 years old, healthy, no drug and supplement consumption
Intervention groups
fasted and fed groups that each group will be divided in 3 subgroups: high intensity interval training, Crossfit training and control
Main outcome variables
Lactate, PDK, CPT-1, UFFA and glucose will be measured

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190213042702N1
Registration date: 2019-09-15, 1398/06/24
Registration timing: retrospective

Last update: 2019-09-15, 1398/06/24
Update count: 0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Maryam Ebrahimi
Name of organization / entity
Faculty of physical education and sport sciences, University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 3377 5209
Email address
maryam.ebrahimi@guilan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2019-04-24, 1398/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of feeding state on some metabolic indices following a single bout of selected Crossfit and high intensity interval exercise in active females
Public title
Effect of feeding state on exercise metabolism
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Physical education students Dorm resident
Exclusion criteria:
Metabolic disorders BMI more than 27 or less than 19 Abnormal PAR-Q Questionnaire musculoskeletal injuries Drug or sport supplements consumption Menstrual cycle
Age
From 17 years old to 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of medical sciences
Street address
Deputy of research and technology, Siadati St, Namjoo St, Rasht/Iran
City
Rasht
Province
Guilan
Postal code
4199843653
Approval date
2019-03-15, 1397/12/24
Ethics committee reference number
IR.GUMS.REC.1398.002

Health conditions studied

1

Description of health condition studied
Healthy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
PDK
Timepoint
Right after the exercise session
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Control group: fasted untrained subjects
Category
Treatment - Other

2

Description
Intervention group 1: fed untrained subjects
Category
Treatment - Other

3

Description
Intervention group 2: 20 minutes of Crossfit exercise including 3 sections, Cardio, Gymnastics and resistance training in fasting state
Category
Treatment - Other

4

Description
Intervention group 3: 20 minutes of Crossfit exercise including 3 sections, Cardio, Gymnastics and resistance training in fed state
Category
Treatment - Other

5

Description
Intervention group 4: 20 minutes of HIIT including 1 min running and 4 min rest periods in fasting state
Category
Treatment - Other

6

Description
Intervention group 5: 20 minutes of HIIT including 1 min running and 4 min rest periods in fed state
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of physical education and sport sciences
Full name of responsible person
Maryam Ebrahimi
Street address
Faculty of physical education and sport sciences, Rasht-Qazvin road
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0255
Email
maryam.ebrahimi@guilan.ac.ir
Web page address
https://staff.guilan.ac.ir/maryam.ebrahimi/?lg=0

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Guilan
Full name of responsible person
Seiied Ziaeddin MirHosseini
Street address
University of Guilan
City
Rasht
Province
Guilan
Postal code
1841
Phone
+98 13 3369 0348
Email
maryam.ebrahimi@guilan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Guilan
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
University of Guilan, Faculty of physical education and sport sciences
Full name of responsible person
Maryam Ebrahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise biochemistry and metabolism
Street address
Faculty of physical education and sport sciences, University of Guilan
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0255
Email
maryam.ebrahimi@guilan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Guilan, Faculty of physical education and sport scineces
Full name of responsible person
Maryam Ebrahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise biochemistry and metabolism
Street address
Faculty of physical education and sport sciences, Rasht-Qazvin road
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0255
Email
maryam.ebrahimi@guilan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Guilan, Faculty of physical education and sport sciences
Full name of responsible person
Maryam Ebrahimi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise biochemistry and metabolism
Street address
University of Guilan, Faculty of physical education and sport sciences
City
Rasht
Province
Guilan
Postal code
4199843653
Phone
+98 13 3369 0255
Email
maryam.ebrahimi@guilan.ac.ir

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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