UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038622 |
|---|---|
| Receipt number | R000043987 |
| Scientific Title | Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function |
| Date of disclosure of the study information | 2020/01/14 |
| Last modified on | 2020/07/16 12:23:26 |
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Basic information
Public title
Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Acronym
Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Scientific Title
Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Scientific Title:Acronym
Examination of the effect of continuous intake of test food for 8 weeks for healthy adults on immune function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects on the immune function of Japanese males and females aged 20 and under 65 by continuously ingesting the test food for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wisconsin upper respiratory symptom survey-21 (WURSS-21)
Key secondary outcomes
POMS2 shortened version, peripheral blood image, NK cell activity, immunity evaluation, each item scores, flow cytometry analysis data, analysis data, secretory IgA
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
8-week intake of the test food
Interventions/Control_2
8-week intake of the placebo food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese male and female aged 20 years or older and younger than 65 years at the time of the informed consent.
2.Subject who is relatively high TMD score of POMS2 shortened version.
3.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria
1.Subject who is taking medication or under medical treatment because of some serious illness.
2.Subject who is under exercise therapy or dietetic therapy.
3.Subject who has an allergy for test food.
4.Subject who has or had a history of either medicine or alcohol dependence syndrome.
5.Subject who has or had a history of mental illness (depression) or sleep disturbance.
6.Subject who is on a night-shift worker.
7.Subject whose lifestyle is extremely irregular.
8.Subject who has an unbalanced diet.
9.Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases person.
10.Subject who uses drugs that may affect immune function (antibiotics, immunosuppressants, anti-inflammatory drugs, antirheumatic drugs, antihistamines, antiallergic drugs, lactic acid bacteria preparations, etc.)
11.Subject who uses health foods that affect immune function (such as yogurt products with functionality (immunity activation)), supplements, and pharmaceuticals
12.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
13.Subject who performs intense exercises such as jogging, marathon and soccer
14.Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition.
15.Subject who is currently pregnant or lactating, or planning to get pregnant.
16.Subject who can't keep the daily records.
17.Subject who is judged to be inappropriate as test subject from clinical laboratory test values and measurement values at the time of SCR.
18.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
ochitani@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
ASAHI CALPIS WELLNESS CO.,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
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
jim@medipharma.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
| 2020 | Year | 01 | Month | 14 | 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
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 23 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2020 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043987
