UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022847 |
|---|---|
| Receipt number | R000026332 |
| Scientific Title | Effect of a fast food diet in combination with high intensity interval training on the cardiometabolic profile of young healthy men. |
| Date of disclosure of the study information | 2016/06/23 |
| Last modified on | 2016/06/23 02:20:31 |
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Basic information
Public title
Effect of a fast food diet in combination with high intensity interval training on the cardiometabolic profile of young healthy men.
Acronym
Fast Food Diet and High Intensity Interval Training
Scientific Title
Effect of a fast food diet in combination with high intensity interval training on the cardiometabolic profile of young healthy men.
Scientific Title:Acronym
Fast Food Diet and High Intensity Interval Training
Region
| North America |
Condition
Condition
Intervention study
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to assess the ability of high intensity exercise to counteract the deleterious effects of a fast food diet on the cardiometabolic profile of young healthy men.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Insulin sensitivity, glucose, insulin
Key secondary outcomes
Lipid, inflammation and hepatic enzyme profiles
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
For 14 consecutive days, participants were subjected to an exclusive fast food diet.
The high intensity interval training (HIIT) program was performed daily for 14 consecutive days on the treadmill. Each exercise session consisted of a 5 min warm-up, followed by 15 x 60 sec sprint intervals (~90% of maximal heart rate) interchanged with 60 sec active recovery (walking) and ended with 5 min cool-down.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
male
aged between 18-30 years old
a body mass index between 18.5-29.9 kg/m2 physically active (> 150 min of physical activity/week)
no orthopedic limitations
non-smoker
low alcohol consumers
Key exclusion criteria
chronic diseases such as cardiovascular disease diabetes and cancer
currently following a fast food diet
gastrointestinal problems such as bloating, nausea, indigestion, constipation and diarrhea
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Antony Karelis |
Organization
University of Quebec at Montreal
Division name
Exercise Science
Zip code
Address
141 President-Kennedy
TEL
514-987-3000
karelis.antony@uqam.ca
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Antony Karelis |
Organization
University of Quebec at Montreal
Division name
Exercise Science
Zip code
Address
141 President-Kennedy, Montreal, Canada
TEL
514-987-3000
Homepage URL
karelis.antony@uqam.ca
Sponsor or person
Institute
University of Quebec at Montreal
Exercise Science
Institute
Department
Personal name
Funding Source
Organization
University of Quebec at Montreal
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Canadian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University of Quebec at Montreal(Department of Exercise
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026332
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
