UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042542
Receipt number R000048565
Scientific Title Effects of meal timing and content on glycemic fluctuations and metabolic responses
Date of disclosure of the study information 2020/11/25
Last modified on 2021/03/23 13:23:08

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Basic information

Public title

Effects of meal timing and content on glycemic fluctuations and metabolic responses

Acronym

Effects of meal timing and content on glycemic fluctuations and metabolic responses

Scientific Title

Effects of meal timing and content on glycemic fluctuations and metabolic responses

Scientific Title:Acronym

Effects of meal timing and content on glycemic fluctuations and metabolic responses

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effects of meals timing and content on glycemic fluctuations and metabolic responses

Basic objectives2

Others

Basic objectives -Others

To clarify the effects of meals timing and content on glycemic fluctuations and metabolic responses

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glucose; Respiratory quotient

Key secondary outcomes

Glucose-related parameters


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

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Other

Interventions/Control_1

Different meal times (18:00 vs. 21:00)
Period; 3 days

Interventions/Control_2

Different meal contents (standard meal vs. high fat meal)
Period; 3 days

Interventions/Control_3


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Healthy adults
2.Nonsmoker

Key exclusion criteria

Those who are taking medication

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Eiichi
Middle name
Last name Yoshimura

Organization

Prefectural University of Kumamoto

Division name

Faculty of Environmental & Symbiotic Sciences

Zip code

862-8502

Address

3-1-100 Tsukide Higashi-ku, Kumamoto

TEL

0963832929

Email

eyoshi@nibiohn.go.jp


Public contact

Name of contact person

1st name Tomoko
Middle name
Last name Ishii

Organization

Prefectural University of Kumamoto

Division name

Regional Cooperation Policy Center

Zip code

862-8502

Address

3-1-100 Tsukide Higashi-ku, Kumamoto

TEL

0963832929

Homepage URL


Email

renkei-c@pu-kumamoto.ac.jp


Sponsor or person

Institute

Prefectural University of Kumamoto

Institute

Department

Personal name



Funding Source

Organization

Support Organization for Securing Stable Supply of Rice

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Regional Cooperation Policy Center

Address

3-1-100 Tsukide Higashi-ku, Kumamoto

Tel

0963832929

Email

renkei-c@pu-kumamoto.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 25 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

14

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

2019 Year 03 Month 18 Day

Date of IRB

2019 Year 03 Month 18 Day

Anticipated trial start date

2019 Year 03 Month 18 Day

Last follow-up date

2020 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 25 Day

Last modified on

2021 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name