UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041933 |
|---|---|
| Receipt number | R000047860 |
| Scientific Title | Exploratory trial of bodily sensation evaluation by test-food intake |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/10/07 09:03:05 |
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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
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
eriko_yoshida@nissui.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047860
