UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory trial of bodily sensation evaluation by test-food intake
Acronym	Exploratory trial of bodily sensation evaluation by test-food intake
Scientific Title	Exploratory trial of bodily sensation evaluation by test-food intake
Scientific Title:Acronym	Exploratory trial of bodily sensation evaluation by test-food intake
Region	Japan

Condition
Condition	Healthy female subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify some kind of clinical effects against a women's poor physical condition, by test food intake.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective evaluation for fatigue Defecation condition Subjective evaluation of skin conditions
Key secondary outcomes

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	Treatment
Type of intervention	Food
Interventions/Control_1	Continuous consumption of the test-food 80 g to the subjects, once a day (between lunch and dinner) for 8 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	69 years-old >=
Gender	Female
Key inclusion criteria	1) Healthy female subjects ranging in age from 20 to 69, at the time point of giving informed consent to take part in this trial. 2) Subjects who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria	1) Subjects with some kind of medical treatment continuously. 2) Subjects taking steadily in the medicine and/or health-specific/functional/health foods, which might affect the test results. 3) Subjects who have been determined as a patient with the chronic fatigue syndrome (CFS), or subjects with severe fatigue just like the idiopathic chronic fatigue, judging from the principal/sub investigator's opinions. 4) Subjects with some kind of medical treatment continuously. 5) Subjects with atopic dermatitis, contact dermatitis and/or skin hypersensitivity. 6) Subjects with excessive suntan, and/or some kind of work/sport outside for a long time. 7) Subjects with some kind of specific care outside, and/or planning to receive the care during this trial. 8) Pregnant, possibly pregnant, or lactating women. 9) Subjects who have previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 10) Subjects with excessive alcohol intake. 11) Subjects with extremely irregular life rhythms, midnight work and/or irregular shift one. 12) Subjects with previous medical history of drug and/or food allergy. 13) Subjects who are now under the other clinical tests with some kind of medicines/foods, or took part in those tests within four weeks after this trial. 14) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Yanagimoto
Organization	Nippon Suisan Kaisha, Ltd.
Division name	Food Function R&D Center
Zip code	1058676
Address	1-3-1 Nishi-Shimbashi, Minato-ku, Tokyo
TEL	080-2098-2093
Email	yanagimoto@nissui.co.jp

Public contact
Name of contact person	1st name Eriko Middle name Last name Yoshida
Organization	Nippon Suisan Kaisha, Ltd.
Division name	Food Function R&D Center
Zip code	1058676
Address	1-3-1 Nishi-Shimbashi, Minato-ku, Tokyo
TEL	080-8088-6685
Homepage URL
Email	eriko_yoshida@nissui.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Nippon Suisan Kaisha, 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2021 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	Completed
Date of protocol fixation	2020 Year 09 Month 23 Day
Date of IRB	2020 Year 09 Month 18 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2020 Year 12 Month 10 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 29 Day
Last modified on	2021 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047860