UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053871 |
|---|---|
| Receipt number | R000061494 |
| Scientific Title | Effect of eating speed on the digestion and absorption rate |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/15 12:55:48 |
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Basic information
Public title
Effect of eating speed on the digestion and absorption rate
Acronym
Effect of eating speed on the digestion and absorption rate
Scientific Title
Effect of eating speed on the digestion and absorption rate
Scientific Title:Acronym
Effect of eating speed on the digestion and absorption rate
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effect of eating speed on digestion and absorption rate
Basic objectives2
Others
Basic objectives -Others
To examine effect of eating speed (rapid eating and slow eating) on digestion and absorption rate
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy loss from stool and urine.
In the eating speed intervention, each trial will be conducted for 8 days.
Key secondary outcomes
Oral and gut microbiota and metabolites, transit time
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rapid eating trial (60% of regular eating duration).
Intervention periods was 8 days (4 days in free living condition and 4 days in laboratory conditions).
Interventions/Control_2
Slow eating trial (200% of regular eating duration).
Intervention periods was 8 days (4 days in free living condition and 4 days in laboratory conditions).
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
- Subjects will be adult males aged 18-39 years who have given informed consent for this study
- Those who habitually defecate more than once a day
Key exclusion criteria
- Under 18 years old
- Over 40 years old
- Females
- Those who habitually do not defecate more than once a day
- Patients with regular medication (diabetes treatment, alpha-blockers, beta-blockers, and other medications that affect metabolism)
- Those who have diseases that affect metabolism (diabetes, thyroid disorders)
- Those with a diagnosis of or history of mental illness
- Patients with pacemakers or other implantable medical devices
- Those with serious cardiovascular disease
- Those with acute stage cancer
- Those who have dental and oral problems
- Those who have a history of gastrointestinal surgery (mainly esophagus, stomach, duodenum, small intestine, colon, and liver. However, appendicectomy is acceptable)
- Those who have gastrointestinal disease
- Those with knee or back problems that interfere with daily life
- Those who have extremely irregular eating habits
- Those who have exercise habits (average 60 minutes/day or more)
- Those who are currently participating in, or intend to participate in, a study involving the ingestion of other foods, the taking of drugs, or the application of cosmetics or drugs, etc.
- Those with drinking and smoking habits and cannot be controlled during the study period
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Yoshimura |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutrition and Metabolism
Zip code
566-0002
Address
Kento Innovation Park NK Building 3-17, Senriokashinmachi, Settsu, Osaka
TEL
0663841120
eyoshi@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Hamada |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutrition and Metabolism
Zip code
566-0002
Address
Kento Innovation Park NK Building 3-17, Senriokashinmachi, Settsu, Osaka
TEL
0663841120
Homepage URL
yhamada@nibiohn.go.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Saito Asagi, Ibaraki-shi, Osaka
Tel
0726419829
irb-office@nibiohn.go.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 | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | 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 | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061494
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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| Registered date | File name |
