UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030895 |
|---|---|
| Receipt number | R000035257 |
| Scientific Title | A study for evaluating psychological and physical effect of intake food at commuting time. A no treatment-controlled, stratified randomization, single-blind, parallel trial. |
| Date of disclosure of the study information | 2018/01/19 |
| Last modified on | 2018/08/03 14:39:15 |
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Basic information
Public title
A study for evaluating psychological and physical effect of intake food at commuting time.
A no treatment-controlled, stratified randomization, single-blind, parallel trial.
Acronym
A study for evaluating psychological and physical effect of intake food at commuting time.
Scientific Title
A study for evaluating psychological and physical effect of intake food at commuting time.
A no treatment-controlled, stratified randomization, single-blind, parallel trial.
Scientific Title:Acronym
A study for evaluating psychological and physical effect of intake food at commuting time.
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence on BMI and body fat due to continuous ingestion of test food at commuting time. And verify the effect of test food on stress that subjects feel during a single attendance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subject's body fat, before test, after 4 and 8 weeks from starting test
Key secondary outcomes
BMI, Body height, body weight, muscle mass, basal metabolic rate and abdominal girth of the subject, 4 and 8 weeks from starting test
Subject's stress felt at attendance time (any day)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food at commuting (8 weeks (work day) ingestion)
Interventions/Control_2
No intake at commuting time (8 weeks (work day))
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 59 years of age
(2) Subjects giving written informed consent
Key exclusion criteria
(1) Individuals who have symptoms that affect test food intake and walking
(2) Currently, individuals are receiving treatment some diseases, especially mental health. Or individuals are using supplements or health foods for stress
(3) Individuals presenting known food allergy in connection with the exam
(4) Individuals who are pregnant
(5) Individuals currently losing weight
(6) Individuals who feel that it is difficult to keep eating test foods during commuting time
(7) Individuals who think are not able to perform the test more than 80% on work day.
(8) Individuals who are judged as unsuitable for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Oosawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory
Zip code
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0275
Oosawa_Kenji@lotte.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Kanno |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory
Zip code
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0187
Homepage URL
Kanno_susumu@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2018 | Year | 01 | Month | 19 | 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
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 13 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035257
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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