UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042572
Receipt number R000048594
Scientific Title The effect of Home-Based High Intensity Interval Exercise (Home-Based HIIE) on postprandial glucose spikes in young adults
Date of disclosure of the study information 2020/11/27
Last modified on 2022/06/30 09:00:36

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Basic information

Public title

The effect of Home-Based High Intensity Interval Exercise (Home-Based HIIE) on postprandial glucose spikes in young adults

Acronym

The effect of Home-Based HIIE on postprandial glucose spikes in young adults

Scientific Title

The effect of Home-Based High Intensity Interval Exercise (Home-Based HIIE) on postprandial glucose spikes in young adults

Scientific Title:Acronym

The effect of Home-Based HIIE on postprandial glucose spikes in young adults

Region

Japan


Condition

Condition

Young adults with postprandial glucose spikes

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate postprandial glucose level after Home-Based HIIE

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glucose Level

Key secondary outcomes

Postprandial glucose peak, Postprandial glucose spike, Incremental area under the curve for postprandial increases in glucose concentration, PACES/J (Physical Activity Enjoyment Scale/Japanese Edition), energy consumption, heart rate, oxygen uptake


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Home-Based HIIE

Interventions/Control_2

Middle Intensity Continuance Exercise

Interventions/Control_3

Keep Sitting Position

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

20 years-old <=

Age-upper limit

30 years-old >=

Gender

Male

Key inclusion criteria

Male students with postprandial glucose spikes who have given written informed consent

Key exclusion criteria

Female, those with motor disorder, those with a history of cardiovascular disease, smokers, those under medication,

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Kumiko
Middle name
Last name ONO

Organization

Kobe University

Division name

Graduate School of Health Sciences

Zip code

654-0142

Address

7-10-2 Tomogaoka, Suma, Hyogo, JAPAN

TEL

078-796-4582

Email

onoku@tiger.kobe-u.ac.jp


Public contact

Name of contact person

1st name Kumiko
Middle name
Last name ONO

Organization

Kobe University

Division name

Graduate School of Health Sciences

Zip code

654-0142

Address

7-10-2 Tomogaoka, Suma, Hyogo, JAPAN

TEL

078-796-4582

Homepage URL


Email

onoku@tiger.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University

Institute

Department

Personal name



Funding Source

Organization

Institute for Food and Health Sciences, Yazuya Co. Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe University Graduate School of Health Sciences, Health Sciences Ethical Committee

Address

7-10-2 Tomogaoka, Suma, Kobe-shi, Hyogo

Tel

078-792-2555

Email

syomu2@ams.kobe-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



Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 27 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

2020 Year 10 Month 27 Day

Date of IRB

2021 Year 05 Month 17 Day

Anticipated trial start date

2021 Year 01 Month 31 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 27 Day

Last modified on

2022 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048594


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name