UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041499 |
|---|---|
| Receipt number | R000047377 |
| Scientific Title | The effects and value food intake on energy consumption |
| Date of disclosure of the study information | 2020/08/21 |
| Last modified on | 2021/03/08 13:50:43 |
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Basic information
Public title
The effects and value food intake on energy consumption
Acronym
The effects and value food intake on energy consumption
Scientific Title
The effects and value food intake on energy consumption
Scientific Title:Acronym
The effects and value food intake on energy consumption
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects and value food intake on energy consumption
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of energy consumption
between the test and control groups
Key secondary outcomes
Comparison of energy consumption
between the test and standing position or walking
Fat consumption
Carbohydrate consumption
Height
Body weight
Muscle mass
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test food
Interventions/Control_2
Control food
Interventions/Control_3
Comparison
Interventions/Control_4
Reference Comparison
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy person over 20 years of age
(2)A person who can refrain from strenuous exercise and drinking the day before the test date
(3)A person who have eaten gum before
and can take it in with no problem
Key exclusion criteria
(1)Pregnat,lactating
(2)A person who take metabolic treatments,medications or supplements
(3)A person who have food allergies
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Osawa |
Organization
Lotte Co., Ltd
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Oosawa_Kenji@lotte.co.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Ooshima |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
Ooshima_Naoya@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2020 | Year | 08 | Month | 21 | 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
20
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 16 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 16 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 16 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 21 | Day |
Last modified on
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047377
