UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045481
Receipt number R000051923
Scientific Title Research on health management based on biological rhythms and Chrono-nutrition
Date of disclosure of the study information 2021/09/15
Last modified on 2024/03/17 21:52:29

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Basic information

Public title

Research on health management based on biological rhythms and Chrono-nutrition

Acronym

Biological rhythms and health management

Scientific Title

Research on health management based on biological rhythms and Chrono-nutrition

Scientific Title:Acronym

Biological rhythms and health management

Region

Japan


Condition

Condition

Diabetes, Obesity

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to examine the validity of a method for evaluating biological rhythms using core body temperature sensors and to clarify the effect of diet (nutrition) on biological rhythms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of biological rhythms using core body temperature sensor

Key secondary outcomes

1) Background survey
2) height
3) weight
4) body composition
5) food frequency questionnaire
6) morningness-eveningness type / Pittsburgh sleep quality index
7) physical activity measured by accelerometer or activity meter
8) evaluation of biological rhythm by glucose measurements by flash glucose monitoring system


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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Breakfast Skipping

Interventions/Control_2

Dinner Skipping

Interventions/Control_3

Caffeine intake at night

Interventions/Control_4

Caffeine intake and light exposure at night

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Men or women in 20-69 who agreed with the research purpose meet the following requirements.
1)who does not have a change in lifestyle in intervention term
2) who can wear a glucose monitor, a physical activity monitor, core body temperature sensor, and eat test meal at a specific time
3)who does not have the custom to exercise

Key exclusion criteria

1) To take medicine related to psychotropic, sleeping, steroid
2) Obesity (BMI>35kg/m2) and sleep apnea syndrome
3) High blood pressure (SBP: above140mmHg, and DBP: above 90mmHg)
4) To take medicine related to diabetes and hyperlipidemia
5) The principal investigator or the principal doctor judge the subject as inappropriate

Target sample size

40


Research contact person

Name of lead principal investigator

1st name shigenobu
Middle name
Last name Shibata

Organization

Waseda University

Division name

Faculty of Science and Engineering

Zip code

162-0056

Address

2-2 Wakamatsu, Shinjuku, Tokyo

TEL

03-5369-7318

Email

shibatas@waseda.jp


Public contact

Name of contact person

1st name Hyeon-Ki
Middle name
Last name Kim

Organization

Waseda University

Division name

School of Advanced Science and Engineering

Zip code

162-0056

Address

2-2 Wakamatsu, Shinjuku, Tokyo

TEL

03-5369-7318

Homepage URL


Email

gusrlgusrl82@gmail.com


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

NTT, Inc.

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

Waseda University

Address

1-104 Totsukamachi, Shinjuku-ku, Tokyo

Tel

03-5272-1639

Email

rinri@list.waseda.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

2021 Year 09 Month 15 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

Main results already published

Date of protocol fixation

2021 Year 03 Month 19 Day

Date of IRB

2021 Year 06 Month 07 Day

Anticipated trial start date

2021 Year 09 Month 15 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

2021 Year 09 Month 14 Day

Last modified on

2024 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name