UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041724 |
|---|---|
| Receipt number | R000047627 |
| Scientific Title | A study for effects on motivation and biomarkers of food containing rice protein hydrolysate intake in healthy adult males and females who are concerned about a decrease in motivation in daily life |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2021/01/19 13:18:38 |
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Basic information
Public title
Effects of rice protein hydrolysate on motivation and biomarkers in healthy adults
Acronym
Effects of rice protein hydrolysate on motivation and biomarkers in healthy adults
Scientific Title
A study for effects on motivation and biomarkers of food containing rice protein hydrolysate intake in healthy adult males and females who are concerned about a decrease in motivation in daily life
Scientific Title:Acronym
A study for effects on motivation and biomarkers of food containing rice protein hydrolysate intake in healthy adult males and females who are concerned about a decrease in motivation in daily life
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of rice protein hydrolysate on motivation and biomarkers in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood scale (POMS2-AS scores, Euthymia scale)
Key secondary outcomes
OSA-MA, STAI-JYZ
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of low-dose food containing rice protein hydrolysate for 2 weeks and single ingestion
Interventions/Control_2
Intake of high-dose food containing rice protein hydrolysate for 2 weeks and single ingestion
Interventions/Control_3
Intake of placebo for 2 weeks and single ingestion
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age
(2) Subjects who are aware of a decline of motivation
1. Subjects who feel exhausted, tired, bushed, bored frequently
2. Subjects who feel energetic, active, lively, motivated rarely
(3) Subjects who correspond to (2) take POMS2-AS. As a result, POMS2-AS FI score is 50 and more, and VA T score is 50 and less
Key exclusion criteria
(1) Subjects who regularly go to mental hospital or fill the standard of Major Depressive Episode
(2) Subjects who are midnight workers, or sleep between 6 a.m. and 10 a.m. and wake up between 6 p.m. and 8 p.m. at least once a week
(3) Subjects who drink an energy drink at least once a week
(4) Subjects who perform an act for the improvement of the fatigue, the quality of the sleep and stress
(5) Subjects who are under treatment or a history of sleep apnea syndrome
(6) Subjects having allergy or having had allergic reaction
(7) Subjects having a disease regularly requiring treatment or a history of malignancy which needed taking a medicine regularly except judged as remission
(8) Subjects who are judged that the results of clinical and physical examination on preliminary examination are more than decision criteria D laid down by Japan Society of Ningen Dock
(9) Subjects who are participated in other clinical study
(10) Subjects who intend to become pregnant or lactating
(11) Subjects who are judged as difficult to carry out the procedures of various tests and to obey the restrictions
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ito |
Organization
KAMEDA SEIKA Co., Ltd.
Division name
Rice Research Institute
Zip code
950-0198
Address
3-1-1 Kameda-kogyodanchi, Konan-ku, Niigata-shi, Niigata
TEL
025-382-8879
a_itou@sk.kameda.co.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Bansho |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
y.bansho@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
t.saito@ttc-smo.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
| 2021 | Year | 11 | Month | 26 | 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
| 2020 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047627
| 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 |
