UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049127 |
|---|---|
| Receipt number | R000055960 |
| Scientific Title | Influence of chewing on after-meal snack intake under constant mealtime conditions crossover randomized controlled trial |
| Date of disclosure of the study information | 2022/10/05 |
| Last modified on | 2022/10/05 16:58:56 |
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Basic information
Public title
Influence of chewing on appetite under constant mealtime conditions
Acronym
Influence of chewing on appetite
Scientific Title
Influence of chewing on after-meal snack intake under constant mealtime conditions crossover randomized controlled trial
Scientific Title:Acronym
Influence of chewing on after-meal snack intake under constant mealtime conditions crossover randomized controlled trial
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exam the effects of the number of chews on fullness and after-meal intake by comparing chewing 15 times and 40 times per a bite under constant mealtime conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy intake of after-meal snack (kcal)
Key secondary outcomes
Fullness measurement by using Visual Analog Scale of appetite
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
1. chewing 15 times per a bite for 11 minutes mealtime(group A)
2. A wash out period (over a 1-week period)
3. chewing 40 times per a bite for 11 minutes mealtime
Interventions/Control_2
1.chewing 40 times per a bite for 11 minutes mealtime(group B)
2. A wash out period (over a 1-week period)
3. chewing 15 times per a bite for 11 minutes mealtime
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
1. To whom can understand questionnaire and answer in Japanese
2. Aged 18 to 39
3. BMI over 18.5, under 25
Key exclusion criteria
1. To whom have food allergy
2. To whom have religious related food restrictions
3. To whom do not like hashed beef rice
4. To whom in diet or food intake restriction
5. To whom have any physical, phycological or dental treatment
6. To whom are smoker
7. Any others judged ineligible as a subject by supervisor or researcher of this research
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Nin |
Organization
Kyouto university
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
6068507
Address
53,Kawaharacho,shogoin,sakyou-ku,Kyoto city, Kyoto
TEL
075-751-3901
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Namiho |
| Middle name | |
| Last name | Moriuchi |
Organization
Kyouto university
Division name
Human Health Sciences, Graduate School of Medicine
Zip code
6068507
Address
53,Kawaharacho,shogoin,sakyou-ku,Kyoto city, Kyoto
TEL
075-751-3901
Homepage URL
moriuchi.namiho.76i@st.kyoto-u.ac.jp
Sponsor or person
Institute
Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Human Health Sciences, Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Research Ethics Committee
Address
Yoshidakonoecho,Sakyou-ku,Kyoto city, Kyoto
Tel
075-753-4642
ethcom@kuhp.kyoto-u.ac.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
京都大学大学院（京都府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 05 | 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 | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 10 | Month | 05 | Day |
Last modified on
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055960
