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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027405
Receipt No. 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

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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
Email 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
Email b2mk@phoenix.ac.jp

Sponsor
Institute Department of Biochemistry, Graduate School of Clinical Pharmacy, Kyushu University of Health and Welfare
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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