UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050267
Receipt number R000052649
Scientific Title Effect of timing of exercise on postprandial glucose concentration
Date of disclosure of the study information 2023/02/09
Last modified on 2024/08/13 09:48:06

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Basic information

Public title

Effect of timing of exercise on postprandial glucose concentration

Acronym

Effect of timing of exercise on postprandial glucose concentration

Scientific Title

Effect of timing of exercise on postprandial glucose concentration

Scientific Title:Acronym

Effect of timing of exercise on postprandial glucose concentration

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The present study aimed to examine the effect of timing and exercise duration on post-meal low exercise after breakfast on postprandial glucose and insulin concentration in young healthy women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

postprandial glucose concentration

Key secondary outcomes

serum insulin concenetration


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Participants started step exercise for 10 min or for 5 min at 30 min after breakfast or no exercise (control) after consuming breakfast in randomized cross-over. Blood glucose and insulin concentrations are examined at 0, 30, 60, and 120 min.

Interventions/Control_2

Participants started step exercise for 10 min or for 5 min at 30 min after breakfast or no exercise (control) after consuming breakfast in randomized cross-over. Blood glucose and insulin concentrations are examined at 0, 30, 60, and 120 min.

Interventions/Control_3

Participants started step exercise for 10 min or for 5 min at 30 min after breakfast or no exercise (control) after consuming breakfast in randomized cross-over. Blood glucose and insulin concentrations are examined at 0, 30, 60, and 120 min.

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

Female

Key inclusion criteria

1. Healthy adults
2. Individuals written informed consents have been obtained
3. Individuals who are judged appropriate for the study by the principal

Key exclusion criteria

1. Patients with type 1 and type 2 diabetes
2. Treatment with steroid
3. Women with possibility of pregnancy or pregnant
4. Severe health problems not suitable for the study

Target sample size

23


Research contact person

Name of lead principal investigator

1st name Saeko
Middle name
Last name Imai

Organization

Kyoto Women's University

Division name

Food and Nutrrition

Zip code

6058501

Address

35, Imakumano, Kitahiyoshi-cho, HIgashiyama-ku, Kyoto

TEL

+81755317128

Email

imais@kyoto-wu.ac.jp


Public contact

Name of contact person

1st name Saeko
Middle name
Last name Imai

Organization

Kyoto Women's University

Division name

Food and Nutrrition

Zip code

6058501

Address

35, Imakumano, Kitahiyoshi-cho, HIgashiyama-ku, Kyoto

TEL

0755317128

Homepage URL


Email

imais@kyoto-wu.ac.jp


Sponsor or person

Institute

Kyoto Women's University

Institute

Department

Personal name



Funding Source

Organization

Kyoto Women's University

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

Kyoto Women's University

Address

35, Imakumano, Kitahiyoshi-cho, HIgashiyama-ku, Kyoto

Tel

+81755317128

Email

imais@kyoto-wu.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

京都女子大学(京都)


Other administrative information

Date of disclosure of the study information

2023 Year 02 Month 09 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

21

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

We are writing the paper, soon we will submit our paper to the journal.

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

2021 Year 10 Month 30 Day

Date of IRB

2021 Year 10 Month 18 Day

Anticipated trial start date

2021 Year 11 Month 01 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry

2023 Year 07 Month 10 Day

Date trial data considered complete

2023 Year 07 Month 15 Day

Date analysis concluded

2023 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2023 Year 02 Month 08 Day

Last modified on

2024 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052649