UMIN-CTR Clinical Trial

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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