UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027951 |
|---|---|
| Receipt number | R000032020 |
| Scientific Title | Estimation of effective intake of the anti-fatigue effects by ingesting functional components for long distance citizen runners |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2017/12/28 16:21:34 |
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Basic information
Public title
Estimation of effective intake of the anti-fatigue effects by ingesting functional components for long distance citizen runners
Acronym
Estimation of effective intake of the anti-fatigue effects by ingesting functional components
Scientific Title
Estimation of effective intake of the anti-fatigue effects by ingesting functional components for long distance citizen runners
Scientific Title:Acronym
Estimation of effective intake of the anti-fatigue effects by ingesting functional components
Region
| Japan |
Condition
Condition
The healthy adults who routinely take long distance
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effective intake of anti-fatigue effects by ingesting functional components
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Evaluation of subjective feelings on fatigue
Key secondary outcomes
(1)Blood analysis
(2)Measurement of running time in full marathon
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the placebo product(8 weeks)
Interventions/Control_2
Oral ingestion of the product containing 2.5g of functional components(8 weeks)
Interventions/Control_3
Oral ingestion of the product containing 5.0g of functional components(8 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Citizen runners of adult
(2)Healthy people
(3)Runners who run a full-marathon in 4 hours 30 minutes
(4)Individuals who have a regular running training
(5)Individuals giving written informed consent
Key exclusion criteria
(1)Individuals who use medical products or regularly see a doctor
(2)Individuals who have serious medical history
(3)Individuals who were participating in other clinical trials within one month
(4)Individuals who have a disorderly dietary life
(5)Individuals who were judged inappropriate by the examining physician
(6)Individuals who have severe allergic disease as alimentary allergy, drug allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiichi Sugiyama |
Organization
Hokkaido University of Education
Division name
Department of Arts and Sports Culture, Sports Coaching Science Course
Zip code
Address
2-34-1, Midorigaoka, Iwamisawa-city, Hokkaido, 068-8642 Japan
TEL
0126-32-0214
sugiyama.kiichi@i.hokkyoudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Kuriki |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
Address
2-5-7, Sengawa, Chofu-city, Tokyo, 182-0002 Japan
TEL
03-5384-7759
Homepage URL
daisuke_kuriki@kewpie.co.jp
Sponsor or person
Institute
Hokkaido University of Education
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
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 | 06 | Month | 28 | 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 | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 29 | 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 | 06 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032020
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
