UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054028 |
|---|---|
| Receipt number | R000061681 |
| Scientific Title | Efficacy study of mealtime regularity on glucose and energy metabolism in healthy male subjects [g2010006] |
| Date of disclosure of the study information | 2024/04/10 |
| Last modified on | 2024/04/01 17:04:44 |
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Basic information
Public title
Efficacy study of mealtime regularity
Acronym
Efficacy study of mealtime regularity
Scientific Title
Efficacy study of mealtime regularity on glucose and energy metabolism in healthy male subjects [g2010006]
Scientific Title:Acronym
Efficacy study of mealtime regularity
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of mealtime regularity on energy and glucose metabolism in healthy men
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
24-hour blood glucose levels after 2-week mealtime intervention
Key secondary outcomes
24-hour energy expenditure, glucose and fat oxidation, respiratory quotient, appetite, physical activity, and diet-induced thermogenesis after a 2-week mealtime intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Randomize meal times by eating three times a day for two weeks.
Interventions/Control_2
Fix meal times by eating three times a day for two weeks.
Interventions/Control_3
Interventions/Control_4
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Participants aged 20 to 64 years old
2) Participants who can received study explanation and agree to participate in this study with written consent
Key exclusion criteria
1) Participants who have serious cardiovascular, hepatic, renal, respiratory, endocrine, metabolic, or gastrointestinal diseases, or who have a medical history of these diseases.
2) Participants who take medicine of hyperlipidemia or diabetes.
3) Participants who have food or medicine allergy.
4) Participants who are claustrophobic
5) Smoker
6) Heavy drinker (Over 30g alcohol per day)
7) Participants who have habitual headaches
8) Participants who are extremely irregular meal times
9) Night worker or shift worker
10) Subjects who considered unsuitable for this study by the study investigators.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7266
hibi.masanobu@kao.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7266
Homepage URL
hibi.masanobu@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Huma R&D CO.Ltd
Address
RBM hamamatsucho Bld.9F,1-27-12,Hamamatsucho,Minato-ku,Tokyo,Japan
Tel
+81-3-3431-1260
rd@huma-c.co.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
| 2024 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
16
Results
None
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
None
Participant flow
None
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061681
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
