UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047787 |
|---|---|
| Receipt number | 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 | 2023/05/19 09:41:26 |
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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
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
shibatas@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
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
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054482
