UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030914
Receipt number 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 2019/11/10 13:10:51

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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 Michiyo
Middle name
Last name Kimura

Organization

Takasaki University of Health and Welfare

Division name

Health and Welfare

Zip code

3700033

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 Michiyo
Middle name
Last name Kimura

Organization

Takasaki University of Health and Welfare

Division name

Health and Welfare

Zip code

3700033

Address

37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan

TEL

027-352-1290

Homepage URL


Email

kimura@takasaki-u.ac.jp


Sponsor or person

Institute

Takasaki University of Health and Welfare

Institute

Department

Personal name



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

Takasaki University of Health and Welfare

Address

37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan

Tel

027-352-1290

Email

mune@takasaki-u.ac.jp


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

8

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

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 11 Month 10 Day

Date analysis concluded

2019 Year 11 Month 10 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 21 Day

Last modified on

2019 Year 11 Month 10 Day



Link to view the page

Value
https://center6.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