UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044527 |
|---|---|
| Receipt number | R000050825 |
| Scientific Title | Effect of functional foods on gut environment of male university athletes. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2023/06/16 09:06:52 |
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Basic information
Public title
Effect of functional foods on gut environment of male university athletes.
Acronym
Effect of functional foods on gut environment of male university athletes.
Scientific Title
Effect of functional foods on gut environment of male university athletes.
Scientific Title:Acronym
Effect of functional foods on gut environment of male university athletes.
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our previous work indicated gut dysbiosis in university male rugby players. In this study, our aim is to evaluate the effects of functional foods on gut environment of university male rugby players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in gut microbiota and organic acids profiles before and after ingestion of functional foods.
Duration of the ingestion is 4 weeks.
Key secondary outcomes
Metabolites of gut microbiota other than organic acids.
Moisture contents of feces.
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Water soluble dietary fiber 12g/day
Blackcurrant extract 150mg/day
Duration of ingestion is 4 weeks
Interventions/Control_2
Water soluble dietary fiber 12g/day
Placebo for Blackcurrant extract
Duration of ingestion is 4 weeks
Interventions/Control_3
Placebo for water soluble dietary fiber
Blackcurrant extract 150mg/day
Duration of ingestion is 4 weeks
Interventions/Control_4
Placebo for water soluble dietary fiber
Placebo for Blackcurrant extract
Duration of ingestion is 4 weeks
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
University male rugby players
Key exclusion criteria
People who have allergy or disease relating gut environment, such as food allergy and/or inflammatory bowel disease.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Inoue |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728965469
ryo.inoue@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Inoue |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, HIrakata, Osaka
TEL
0728965469
Homepage URL
ryo.inoue@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku Corporation
Morishita Jintan 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
Setsunan University
Address
17-8, Ikedanaka-cho, Neyagawa, Osaka
Tel
072-800-1160
SETSUNAN.Kenkyu.Shakai@josho.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 | 11 | Month | 01 | 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 | 05 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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 | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050825
