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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041724
Receipt No. 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

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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
Email 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
Email y.bansho@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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