UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045840 |
|---|---|
| Receipt number | R000052331 |
| Scientific Title | A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2021/10/22 18:13:17 |
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Basic information
Public title
A study to evaluate the effect of food ingredient in healthy adult on the immune system
-Placebo-controlled, randomized, double-blind, parallel-group comparative method
Acronym
A study to evaluate the effect of food ingredient in healthy adult on the immune system
-Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title
A study to evaluate the effect of food ingredient in healthy adult on the immune system
-Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title:Acronym
A study to evaluate the effect of food ingredient in healthy adult on the immune system
-Placebo-controlled, randomized, double-blind, parallel-group comparative method
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test food intake for 8 consecutive weeks on immune function using placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune function
Key secondary outcomes
Physical condition questionnaire
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
Ingestion of test food (research food)
Interventions/Control_2
Ingestion of placebo
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Japanese males and females from 20 to 64 years of age
(2) Subjects who are aware that they are susceptible to cold
(3) Subjects who do not plan to be vaccinated against coronavirus, influenza virus, etc. during the study period
(4) Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate with a good understanding, and have agreed in writing to participate in the study
Key exclusion criteria
(1)Subjects who regularly intake food containing involvement ingredients at least 3 times a week
(2)Subjects suffering from, undergoing treatment for, or with a history of serious diseases
(3)Subjects who have chronic diseases and take medication on a daily basis
(4)Subjects who regularly use medicines, food for specified health use or functional food, or health food that may affect immunity
(5)Subjects who have a habit of taking lactobacillus-rich foods or lactobacillus preparations at least three times a week
(6)Subjects who consistently drink more than the appropriate amount of alcohol
(7)Subjects who are unable to abstain from alcohol for 2 days prior to screening test and each test
(8)Subjects who have food allergies
(9)Subjects who are undergoing treatments that may affect the research results
(10)Subjects who work day and night shifts or engage in physical labor such as carrying heavy loads
(11)Subjects who habitually engage in intense physical activities such as marathon (12)Subjects who fail to follow the prescribed procedures for the various tests during the study
(13)Subjects with digestive diseases affecting digestion and absorption and Subjects with a history of digestive surgery
(14)Pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding
(15)Subjects who are judged to be inappropriate as research subjects based on blood tests
(16)Subjects who have a history or current condition of drug or alcohol dependence
(17)Subjects who are participating in research involving the ingestion of other foods or the use of other medicines
(18)Subjects who plan to travel abroad, including overseas travel, during the study
(19)Subjects who has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components
(20)Subjects who judges to be inappropriate as research subjects by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Tanaka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
tomomi_tanaka@kewpie.co.jp
Sponsor or person
Institute
KSO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2, Gokanmachi, maebashishi, Gunma
Tel
027-261-7600
sagawa@mc-connect.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 | 22 | 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
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052331
