UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041223
Receipt number R000047045
Scientific Title Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition
Date of disclosure of the study information 2020/08/01
Last modified on 2022/05/25 11:05:36

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Basic information

Public title

Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition

Acronym

Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition

Scientific Title

Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition

Scientific Title:Acronym

Examination of changes in Blood Glucose Levels during ingestion of various foods in Chrono Nutrition

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test whether dietary habits are actually improved by taking a variety of food products based on Chrono Nutrition.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of Blood Glucose level accompany eating

Key secondary outcomes

Subjective and Objective sleep quality


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The subjects are attached Free Style Libre for monitoring brood glucose level.At the same time, the subjects are attached Fitbit for monitoring sleep quality. (2 weeks)

1) Eat test meal as asnacks.

Interventions/Control_2

2) Eat glucose as asnacks.

Interventions/Control_3

3) Eat test meal after dinner.

Interventions/Control_4

4) Do not eat between snacks.

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

19 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1.Healthy adults over 19 years of age
2.A subject who related of a school in Aikoku Gakuen Junior College
3.The subject who provided written consent for participation

Key exclusion criteria

1.The subject that cannot cooperate in response to explanation of this examination.
2.The Subject more than BMI 30.
3.The subject whose supervisors judged participation to be inappropriate.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kazuko
Middle name
Last name Hirao

Organization

Aikoku Gakuen Junior College

Division name

Department of Home Economics

Zip code

133-8585

Address

5-7-1, Nishikoiwa, Edogawa-ku, Tokyo

TEL

03-5668-7260

Email

hirao@aikoku-jc.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Furutani

Organization

Aikoku Gakuen Junior College

Division name

Department of Home Economics

Zip code

133-8585

Address

5-7-1, Nishikoiwa, Edogawa-ku, Tokyo

TEL

03-5668-7260

Homepage URL


Email

a.furutani@kurenai.waseda.jo


Sponsor or person

Institute

Aikoku Gakuen Junior College

Institute

Department

Personal name



Funding Source

Organization

Calbee, Inc.

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

Aikoku Gakuen Junior College

Address

5-7-1, Nishikoiwa, Edogawa-ku, Tokyo

Tel

03-5668-7260

Email

aioffice@aikoku-jc.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 08 Month 01 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

Open public recruiting

Date of protocol fixation

2019 Year 11 Month 21 Day

Date of IRB

2020 Year 01 Month 08 Day

Anticipated trial start date

2020 Year 01 Month 09 Day

Last follow-up date

2023 Year 03 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 07 Month 27 Day

Last modified on

2022 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047045


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name