UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045372 |
|---|---|
| Receipt number | R000051798 |
| Scientific Title | Effects of food intake on immunity, autonomic nerves and stress |
| Date of disclosure of the study information | 2021/09/06 |
| Last modified on | 2022/03/08 09:17:37 |
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Basic information
Public title
Effects of food intake on immunity, autonomic nerves and stress
Acronym
Effects of food intake on immunity, autonomic nerves and stress
Scientific Title
Effects of food intake on immunity, autonomic nerves and stress
Scientific Title:Acronym
Effects of food intake on immunity, autonomic nerves and stress
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of effects on immunity, autonomic nerves and stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
POMS2, autonomic nerves, saliva volume, salivary IgA, cortisol, chromogranin A, BDNF, NK cell activity, phagocytic ability of the neutrophils, lymphocyte transformation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food (continuous intake)
Interventions/Control_2
No intake
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults in their 20s to 50s
(2) Subjects giving written informed consent
Key exclusion criteria
(1)Individuals having diseases that affect saliva production
(2)Individuals having symptoms that affect test food ingestion
(3)Individuals taking medications that may affect results
(4)Individuals who may develop allergies in connection with the test
(5)Individuals who have the will of pregnancy or are breast-feeding during the study period
(6)Individuals deemed inappropriate by the study director to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Osawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
oosawa_kenji@lotte.co.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Matsui |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
matsui_misaki@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobayashi Medical Clinic Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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 | 09 | Month | 06 | 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
50
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
| 2021 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 08 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 08 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051798
