UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049013 |
|---|---|
| Receipt number | R000055711 |
| Scientific Title | Effects of consumption of the test food on immune, intestinal environment and skin in healthy subjects: A randomized, double-blind, parallel-group, placebo-controlled study |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2023/03/10 13:24:30 |
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Basic information
Public title
Effects of consumption of the test food on immune, intestinal environment and skin in healthy subjects
Acronym
Effects of consumption of the test food on immune, intestinal environment and skin in healthy subjects
Scientific Title
Effects of consumption of the test food on immune, intestinal environment and skin in healthy subjects: A randomized, double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym
Effects of consumption of the test food on immune, intestinal environment and skin in healthy subjects
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the test food on immune, intestinal environment or skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sIgA in saliva, Statum corneum moisture content, Trans epidermal water loss, pH of feces, Organic acids in feces, Phenols in feces
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the test food (2 pills/day; 8 weeks)
Interventions/Control_2
Oral ingestion of the placebo food (2 pills/day; 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Subjects agreeing to participate in the study with signing a written informed consent
2. Subjects aged 20 or more
3. Women
4. Healthy subjects
Key exclusion criteria
1. Subjects currently being treated for severe renal or liver disease, heat, respiratory or endocrine disease, or other metabolic diseases.
2. Subjects who can't stop use of supplements for immune, intestinal function or skin.
3. Subjects who have a history of allergic symptoms by the ginseng.
4. Subjects who participated in other clinical studies.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Takaoka |
Organization
Kobe college
Division name
School of human sciences
Zip code
662-8505
Address
4-1 Okada-yama, Nishinomiya Hyogo
TEL
0798-51-8423
takaoka@mail.kobe-c.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Takaoka |
Organization
Kobe college
Division name
School of human sciences
Zip code
662-8505
Address
4-1 Okada-yama, Nishinomiya Hyogo
TEL
0798-51-8423
Homepage URL
takaoka@mail.kobe-c.ac.jp
Sponsor or person
Institute
Kobe college
Institute
Department
Personal name
Funding Source
Organization
Nagase Beauty Care & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagase Beauty Care & Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe college school of human sciences research ethics committee
Address
4-1 Okada-yama, Nishinomiya Hyogo
Tel
0798-51-8553
maseda@mail.kobe-c.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
| 2022 | Year | 09 | 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
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | 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 | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055711
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
