UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026866 |
|---|---|
| Receipt number | R000030829 |
| Scientific Title | Impact on immune function by ingesting Natto |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2017/04/05 12:11:40 |
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Basic information
Public title
Impact on immune function by ingesting Natto
Acronym
Impact on immune function by ingesting Natto
Scientific Title
Impact on immune function by ingesting Natto
Scientific Title:Acronym
Impact on immune function by ingesting Natto
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the influence on immune function when feeding Natto for 8 weeks, for middle-aged and elderly subjects whose immune function tends to decline.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Secretory immunoglobulin A (S-IgA)
Key secondary outcomes
Tiredness/Feeling (VAS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Natto
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women of ages 50 to 64 years old
Key exclusion criteria
1. Persons who have symptoms of hay fever and perennial allergic rhinitis
2. Persons who have diseases in the oral cavity such as periodontal disease or dry mice
3. Person who has heart disease
4. Person who take warfarin
5. Person who has a history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, other severe disease
6. Persons who show impaired cardiopulmonary function
7. Persons who liver function and renal function test values show abnormalities
8. Persons who have had surgery on the gastrointestinal tract
9. Currently, those with a disorder under treatment
10. Persons who have food or drug allergy
11. Persons who do intense sports or are on a diet
12. Persons who are taking health foods, quasi medical items, medicines (including OTC, prescription medicine) containing ingredients contained in the test food
13. Persons who consume excess alcohol or can not abstinence from the day before the test until the day
14. Persons who are pregnant, or persons who are planning to become pregnant or breastfeeding during the study period
15. Persons who are participating in the other study or planning to participate during the study period
16. Persons who judged inappropriate by the study responsible doctor for other reasons
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal Medicine
Zip code
Address
9F Higashitenma Bldg.,1-7-17 Higashitenma, Kita-ku, Osaka-shi, Osaka, Japan
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical trial Division
Zip code
Address
9F Higashitenma Bldg.,1-7-17 Higashitenma, Kita-ku, Osaka-shi, Osaka, Japan
TEL
06-4801-8917
Homepage URL
mterashima@miura-cl.jp
Sponsor or person
Institute
Takanofoods Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Takanofoods Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Miura Clinic, Medical Corporation Kanonkai
Oneness Support Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2017 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030829
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
