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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | healthy adults | ||
Classification by specialty |
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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 |
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Interventions/Control_1 | placebo | |
Interventions/Control_2 | indigestible dextrin | |
Interventions/Control_3 | Lactobacillus
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Interventions/Control_4 | indigestible dextrin
and Lactobacillus |
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.healty persons aged between 20 and 70.
2.persons who provided written consent for participation. |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |