UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043726 |
|---|---|
| Receipt number | 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 17:46:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shigeru.saito@t.matsu.ac.jp
Sponsor or person
Institute
Matsumoto University
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
Matsumoto University
Address
2095-1, Niimura, Matsumoto-city, Nagano
Tel
0263-48-7340
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049928
