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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043726
Receipt No. R000049928
Scientific Title Effects of test food on subjective symptoms in healthy subjects who exercise regularly: a randomized, double-blind, placebo-controlled trial.
Date of disclosure of the study information 2021/03/24
Last modified on 2021/10/26

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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/ctr_e/ctr_view.cgi?recptno=R000049928

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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