UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effect of test food on the mental and physical condition. -randomized, placebo-controlled, double-blind, parallel-group trial-
Acronym	A study of the effect of test food on the mental and physical condition.
Scientific Title	A study of the effect of test food on the mental and physical condition. -randomized, placebo-controlled, double-blind, parallel-group trial-
Scientific Title:Acronym	A study of the effect of test food on the mental and physical condition.
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This trial aims to investigate the effect of 8 weeks intake of the test food on the mental and physical condition in healthy subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL questionnaire intestinal microbiota blood markers test
Key secondary outcomes

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	Take test food with water or warm water for 8 weeks.
Interventions/Control_2	Take placebo food with water or warm water for 8 weeks.
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	1. Healthy subjects over 18 years old 2. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement Those who have no history of smoking within a year
Key exclusion criteria	1. Those who have been currently visiting a hospital or treated with any drug for any disease 2. Those who currently have or have history of severe diseases 3. Those who joined other clinical trials within 1 month before receiving informed consent in this study, or those who are currently joining other clinical trials 4. Those who are judged by the physician to be unsuitable for this study. 5. Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Ozeki
Organization	Taiyo Kagaku Co., Ltd
Division name	Nutrition Division
Zip code	510-0844
Address	1-3 Takaramachi, Yokkaichi, Mie 510-0844, Japan
TEL	059-347-5411
Email	mozeki@taiyokagaku.co.jp

Public contact
Name of contact person	1st name Aya Middle name Last name Abe
Organization	Taiyo Kagaku Co., Ltd
Division name	Nutrition Division
Zip code	510-0844
Address	1-3 Takaramachi, Yokkaichi, Mie 510-0844, Japan
TEL	059-347-5411
Homepage URL
Email	aabe@taiyokagaku.co.jp

Sponsor
Institute	Seitoku University
Institute
Department

Funding Source
Organization	Taiyo Kagaku Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Seitoku university ethics committee for human study
Address	550 Iwase, Matsudo-shi, Chiba, 271-8555, Japan
Tel	047-365-1111
Email	ethics.committee@wa.seitoku.ac.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	2023 Year 10 Month 01 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	2022 Year 05 Month 26 Day
Date of IRB	2022 Year 05 Month 26 Day
Anticipated trial start date	2022 Year 10 Month 01 Day
Last follow-up date	2023 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 27 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055793