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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047787
Receipt No. R000054482
Scientific Title Effect of meal difference and timing on human health
Date of disclosure of the study information 2022/05/18
Last modified on 2022/05/18

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Basic information
Public title Effect of meal difference and timing on human health
Acronym Effect of meal difference and timing on human health
Scientific Title Effect of meal difference and timing on human health
Scientific Title:Acronym Effect of meal difference and timing on human health
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the effects of meal timing on various health markers like blood glucose, BMI, physical activity and mental hygiene.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changing in tissue glucose level
Key secondary outcomes Subjective questionnaire survey.
OSA sleep survey

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 placebo
Interventions/Control_2 indigestible dextrin
Interventions/Control_3 Lactobacillus
Interventions/Control_4 indigestible dextrin
and Lactobacillus
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 1.healty persons aged between 20 and 70.
2.persons who provided written consent for participation.
Key exclusion criteria 1)individuals with diabetes and lipid abnormality.2) individuals taking supplement and/or drug which act metabolism. 3)Individuals taking antipsychotic and hypnotic and steroid drugs. 4)Individuals who takes smoking . 5)Individuals with severe heart disease.6) individuals who take social jet lag and shift work.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Shigenobu
Middle name
Last name Shibata
Organization Waseda University
Division name School of Science and Engineering
Zip code 162-0056
Address Wakamatsu-cho, Shijuku-ku
TEL +81353697318
Email shibatas@waseda.jp

Public contact
Name of contact person
1st name Shigenobu
Middle name
Last name Shibata
Organization Waseda University
Division name School of Science and Engineering
Zip code 162-0056
Address Wakamatsu-cho, Shijuku-ku
TEL +81903807522
Homepage URL
Email shibatas@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Waseda University
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 Nishiwaseda, Shinjuku-ku
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 早稲田大学 先端生命医科学センター

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 18 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2022 Year 05 Month 18 Day
Last follow-up date
2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 18 Day
Last modified on
2022 Year 05 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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