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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030914
Receipt No. R000035300
Scientific Title Influence of diet-induced thermogenesis on warming up before exercise under cold environment
Date of disclosure of the study information 2018/01/21
Last modified on 2019/03/19

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Basic information
Public title Influence of diet-induced thermogenesis on warming up before exercise under cold environment
Acronym Influence of DIT on warming up under cold environment
Scientific Title Influence of diet-induced thermogenesis on warming up before exercise under cold environment
Scientific Title:Acronym Influence of DIT on warming up under cold environment
Region
Japan

Condition
Condition Normal
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the diet compositions that is effective in shortening warming-up time before exercise and maintaining body temperature by DIT under cold environment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diet compositions
Key secondary outcomes Rectal temparature
Skin temparature
Energy expenditure

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 No ingestion of a test food > warming-up exercise(Ergometer exercise 20min, 130bpm)
All subjects will receive five treatments on five separate days over an interval of at least 6 days.
Interventions/Control_2 Ingestion of a test food A > warming-up exercise(Ergometer exercise 20min, 130bpm)
Interventions/Control_3 Ingestion of a test food B > warming-up exercise(Ergometer exercise 20min, 130bpm)
Interventions/Control_4 Ingestion of a test food C > warming-up exercise(Ergometer exercise 20min, 130bpm)
Interventions/Control_5 Ingestion of a test food D > warming-up exercise(Ergometer exercise 20min, 130bpm)
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
24 years-old >=
Gender Male and Female
Key inclusion criteria Healthy university students who have the exercise habit and have given written informed consent
Key exclusion criteria 1)heart disease and/or respiratory disease and/or injury
2)take medicine
3)food allergies
4)smoking habit
5)food-dependent exercise-induced anaphylaxis
6)menstrual irregularity (women only)
7)other reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiyo Kimura
Organization Takasaki University of Health and Welfare
Division name Health and Welfare
Zip code
Address 37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
TEL 027-352-1290
Email kimura@takasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiyo Kimura
Organization Takasaki University of Health and Welfare
Division name Health and Welfare
Zip code
Address 37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan
TEL 027-352-1290
Homepage URL
Email kimura@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 高崎健康福祉大学

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 21 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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
2018 Year 01 Month 11 Day
Anticipated trial start date
2018 Year 01 Month 20 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 21 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035300

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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