UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033953 |
|---|---|
| Receipt number | R000038718 |
| Scientific Title | Evaluation of immunostimulatory effects of foods |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2019/06/27 08:50:06 |
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Basic information
Public title
Evaluation of immunostimulatory effects of foods
Acronym
Evaluation of immunostimulatory effects of foods
Scientific Title
Evaluation of immunostimulatory effects of foods
Scientific Title:Acronym
Evaluation of immunostimulatory effects of foods
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the immunostimulatory effects of the foods on CD69 and other markers expression on T cells
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CD69 expression on T cells
Key secondary outcomes
Expressions of activation markers on T cells
Expressions of senescence markers on T cells
Lymphocyte blastoid transformation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (112 mL) once a day for 3 weeks
Interventions/Control_2
Oral intake of the placebo (112mL) once a day for 3 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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who have given written informed consent
2) Subjects aged 30 to 65 years old
3) Subjects whose body mass index (BMI) is from 18.5 kg/m2 to 24.9 kg/m2
4) Subjects who have not received a vaccination within the past half year and are not planning to get a vaccination during the study.
Key exclusion criteria
1) Subjects who have immune related diseases or its medical histories
2) Cancer patients
3) Subjects who have psychological diseases
4) Subjects who have infectious diseases
5) Subjects who have asthma, food allergy, atopic dermatitis or their medical histories
6) Subjects who intake anti-inflammatory drugs, immunosuppressants, antibiotics, anti-allergic drugs
7) Subjects who are pregnant, or wish to be pregnant during the study
8) Lactating women
9) Subjects who are intolerant to lactose
10) Smokers
11) Subjects who have a habit to take alcohol(expressed in amount of alcohol: over 60 g/day)
12) Subjects who have a habit to take fermented milks, foods for specified health use, or dietary supplements containing probiotics more than once a day
13) Subjects who have a habit to take pharmaceuticals, health foods or dietary supplements containing ingredients can affect immune system more than 3 times a week within past 2 weeks
14) Subjects who have participated in other clinical trials within a month or plan to participate other clinical trials during this study period
15) Subjects who are judged not suitable to participate in this trial by principal investigator or subinvestigators
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Asami |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology Research Laboratories, R&D Division
Zip code
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
TEL
042-632-5842
yukio.asami@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiya Makino |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology Research Laboratories, R&D Division
Zip code
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
TEL
042-632-5842
Homepage URL
seiya.makino@meiji.com
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Address
Tel
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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 18 | 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
| 2018 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 06 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038718
