UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a fast food diet in combination with high intensity interval training on the cardiometabolic profile of young healthy men.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Antony Karelis
Organization	University of Quebec at Montreal
Division name	Exercise Science
Address	141 President-Kennedy
TEL	514-987-3000
Email	karelis.antony@uqam.ca

Public contact
Name of contact person	Antony Karelis
Organization	University of Quebec at Montreal
Division name	Exercise Science
Address	141 President-Kennedy, Montreal, Canada
TEL	514-987-3000
Homepage URL
Email	karelis.antony@uqam.ca

Sponsor
Institute	University of Quebec at Montreal Exercise Science
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026332