UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027405 |
|---|---|
| Receipt number | R000031404 |
| Scientific Title | Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial. |
| Date of disclosure of the study information | 2017/05/19 |
| Last modified on | 2017/11/20 18:40:19 |
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Basic information
Public title
Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial.
Acronym
Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial.
Scientific Title
Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial.
Scientific Title:Acronym
Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of ingestion of test food on immune parameters and state of health of healthy adults in summer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune parameters (natural killer cell cytotoxicity, Neutrophil phagocytic capacity, sIgA)
State of health in summer (infectious diseases etc)
Key secondary outcomes
Balance of the autonomic nervous system
Cortisol
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
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food (high dose) for 12 weeks
Interventions/Control_2
Ingestion of test food (low dose) for 12 weeks
Interventions/Control_3
Ingestion of placebo for 12 weeks
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
Aged from 20 to 64 years old
Key exclusion criteria
1) Subjects with chronic diseases
2) Subjects in pregnancy or breast-feeding
3) Subjects with milk allergy
4) Subjects who consume test food habitually
5) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
6) Subjects who are judged inappropriate to this trial by the investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Kurokawa |
Organization
Kyushu University of Health and Welfare
Division name
Department of Biochemistry, Graduate School of Clinical Pharmacy
Zip code
Address
1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
TEL
0982-23-5574
b2mk@phoenix.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Kurokawa |
Organization
Kyushu University of Health and Welfare
Division name
Department of Biochemistry, Graduate School of Clinical Pharmacy
Zip code
Address
1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
TEL
0982-23-5574
Homepage URL
b2mk@phoenix.ac.jp
Sponsor or person
Institute
Department of Biochemistry, Graduate School of Clinical Pharmacy, Kyushu University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 19 | 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
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 22 | 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 | 05 | Month | 19 | Day |
Last modified on
| 2017 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031404
