UMIN-CTR Clinical Trial

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 male and female 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 male and female 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 for 4 weeks and single ingestion
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	Insomnia Severity Inventory

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of food containing rice protein hydrolysate for 4 weeks and single ingestion
Interventions/Control_2	Intake of placebo for 4 weeks and single ingestion
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	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 have taken POMS2-AS on preliminary examination(2) and (3) and have scored FI T score 50 points and more, and VA T score 50 points and less at least once
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 having allergy or having had allergic reaction (6) Subjects having a disease regularly requiring treatment or a history of malignancy which needed taking a medicine regularly except judged as remission (7) 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 (8) Subjects who are participated in other clinical study (9) Subjects who intend to become pregnant or lactating (10) Subjects who are judged as difficult to carry out the procedures of various tests and to obey the restrictions
Target sample size	76

Research contact person
Name of lead principal investigator	1st name Kimiko Middle name Last name Uchiyama
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	k_uchiyama@sk.kameda.co.jp

Public contact
Name of contact person	1st name Yoshimi Middle name Last name Bansho
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Tsuruya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	03-5657-4983
Homepage URL
Email	bansho.yoshimi189@eps.co.jp

Sponsor
Institute	EP Mediate 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	080-2290-2544
Email	makabe.akio295@eps.co.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	2022 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	2021 Year 07 Month 08 Day
Date of IRB	2021 Year 07 Month 08 Day
Anticipated trial start date	2021 Year 08 Month 03 Day
Last follow-up date	2021 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	2021 Year 08 Month 02 Day
Last modified on	2022 Year 07 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051444