UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020962 |
|---|---|
| Receipt number | R000024186 |
| Scientific Title | A study on efficacy of functional peptide-containing drink |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2018/08/13 11:40:16 |
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Basic information
Public title
A study on efficacy of functional peptide-containing drink
Acronym
A study on efficacy of functional peptide-containing drink
Scientific Title
A study on efficacy of functional peptide-containing drink
Scientific Title:Acronym
A study on efficacy of functional peptide-containing drink
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of taking functional peptide-containing drink for four weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress reaction before and after the trial by POMS and the brief job stress questionnaire
Key secondary outcomes
Physical activity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The functional peptide drink is taken every day for four weeks.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who can make self-judgment and agree to participate this trial.
Key exclusion criteria
1) Subjects who have continuous medical treatment.
2) Subjects who are pregnant or have possibility to become pregnant or planning to become pregnant during the study or breast-feeding woman.
3) Subjects who are contracting kidney disease.
4) Subjects who have allergic reaction to food.
5) Subjects who are judged as unsuitable for the study by this study responsibility physician for other reasons.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihito Murayama |
Organization
Suntory Global Innovation Center Ltd.
Division name
Innovation Development Department
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284 Japan
TEL
050-3182-0588
Norihito_Murayama@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Takano |
Organization
Suntory Global Innovation Center Ltd.
Division name
Innovation Development Department
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL
050-3182-0598
Homepage URL
Jiro_Takano@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center 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
Division of Psychosomatic Medicine, Teikyo University Hospital, Teikyo University School of Medicine
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
| 2016 | Year | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024186
| 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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| Registered date | File name |
