UMIN-CTR Clinical Trial

Basic information
Public title	Effects of test food on subjective symptoms in healthy subjects who exercise regularly: a randomized, double-blind, placebo-controlled trial.
Acronym	Effects of test food on subjective symptoms in healthy subjects who exercise regularly.
Scientific Title	Effects of test food on subjective symptoms in healthy subjects who exercise regularly: a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym	Effects of test food on subjective symptoms in healthy subjects who exercise regularly.
Region	Japan

Condition
Condition	None (Healthy subjects)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of test food on subjective symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective symptoms
Key secondary outcomes	Immune indices

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food for 4 weeks.
Interventions/Control_2	Ingestion of placebo for 4 weeks.
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	1) Male subjects between 18 to 65 years old. 2) Subjects who exercise regularly.
Key exclusion criteria	1) Subjects who can not stop taking supplements or functional foods which may affect immune functions. 2) Subjects having a milk allergy. 3) Subjects who have a history of serious allergic disease. 4) Subjects who need the application of medicine containing steroids. 5) Subjects who regularly consume foods containing an active ingredients. 6) Extremely heavy drinkers (more than 60g/day of alcohol). 7) Subjects who can not sleep at night due to irregular work or other reasons. 8) Subjects who are being treated for chronic disease. 9) Subjects who are positive in the pathogen test. 10) Subjects who have serious disease in the liver, kidney heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these. 11) Subjects whose research managers judged inappropriate as subjects.
Target sample size	84

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name Saito
Organization	Matsumoto University
Division name	Graduate School of Health Science
Zip code	390-1295
Address	2095-1, Niimura, Matsumoto-city, Nagano
TEL	0263-48-7340
Email	shigeru.saito@t.matsu.ac.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Saito
Organization	Matsumoto University
Division name	Graduate School of Health Science
Zip code	390-1295
Address	2095-1, Niimura, Matsumoto-city, Nagano
TEL	0263-48-7340
Homepage URL
Email	shigeru.saito@t.matsu.ac.jp

Sponsor
Institute	Matsumoto University
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	Matsumoto University
Address	2095-1, Niimura, Matsumoto-city, Nagano
Tel	0263-48-7340
Email	shigeru.saito@t.matsu.ac.jp

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 03 Month 24 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	2021 Year 03 Month 08 Day
Date of IRB	2021 Year 03 Month 08 Day
Anticipated trial start date	2021 Year 03 Month 25 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 24 Day
Last modified on	2021 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049928