UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046959 |
|---|---|
| Receipt number | R000053385 |
| Scientific Title | Examination of the effects induced by research-food intakes continuously on immune parameters. |
| Date of disclosure of the study information | 2022/02/23 |
| Last modified on | 2023/08/24 11:31:09 |
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Basic information
Public title
Examination of the effects induced by research-food intakes continuously on immune parameters.
Acronym
Examination of the effects induced by research-food intakes continuously on immune parameters.
Scientific Title
Examination of the effects induced by research-food intakes continuously on immune parameters.
Scientific Title:Acronym
Examination of the effects induced by research-food intakes continuously on immune parameters.
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate some kind of effect by the research-food intakes continuously for eight weeks, on the immune parameters
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The analysis of the immune cell
Key secondary outcomes
The antibody test of the saliva
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 with water/lukewarm to the subjects at breakfast, 1 drop a day.
Interventions/Control_2
Oral ingestion of the placebo food with water/lukewarm to the subjects at breakfast, 1 drop a day.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 20 to 69 at informed consent.
(2) Subjects with no smoking (not less than one year).
(3) Subjects having not less than 18.5 kg/m2, but less than 30.0 kg/m2 of BMI.
(4) Subjects who can observe the rules (meals and behaviors) on the previous/appointed test days.
(5) Subjects who can give informed consent to participate in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) who take steadily (not less than 3 times a week) in the health-specific/functional/supplementary/health foods (e.g., immune function).
(2) with excessive alcohol intake.
(3) who will be under a large variable condition, such as house-moving, transfer, diet.
(4) with extremely irregular eating habits / life rhythm (irregular shift work or midnight one).
(5) with history of tonsil/appendix removal.
(6) who have received affecting surgeries (colonoscopy, gallstones/gall bladder removal, gastric bypass) within half a year before the consent.
(7) with any difficulty in giving up taking medicines (e.g., antibiotics, steroids, antihistamines) during this research.
(8) who have taken antibiotics within the last month before beginning the research-food intakes, or will take those.
(9) having continuous allergy, and will take medicine.
(10) undergoing dental treatment for gingivitis/periodontitis, or bleeding daily in the mouth.
(11) with heavy exercises, not less than 4 days a week.
(12) being under other clinical researches, or participated in those within the last four weeks before this research, or will join those after the consent.
(13) will vaccinate within the designated periods.
(14) whose roomer/acquaintance will take part in this research.
(15) with medical history of serious diseases in heart, liver, kidney or digestive organs.
(16) with pregnant, possibly pregnant, or lactating.
(17) having drug/food allergy.
(18) donated their blood components and/or whole blood (0.2 L) within a month to this research.
(19) donated his whole blood (0.4 L) within the last 3 months to this research.
(20) donated her whole blood (0.4 L) within the last 4 months to this research.
(21) being collected in total of his blood (1.2 L) within the last 12 months and in this research.
(22) being collected in total of her blood (0.8 L) within the last 12 months and in this research.
(23) determined as ineligible for participation, by the principal/sub investigator - -.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Senior Researcher
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu-shi, Shiga 520-0002, Japan
TEL
077-521-8835
Saito.Takao@otsuka.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Macromill, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2022 | Year | 02 | Month | 23 | 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 | 01 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 09 | 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 | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053385
