UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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	Masahiko Kurokawa
Organization	Kyushu University of Health and Welfare
Division name	Department of Biochemistry, Graduate School of Clinical Pharmacy
Address	1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
TEL	0982-23-5574
Email	b2mk@phoenix.ac.jp

Public contact
Name of contact person	Masahiko Kurokawa
Organization	Kyushu University of Health and Welfare
Division name	Department of Biochemistry, Graduate School of Clinical Pharmacy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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