UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053130 |
|---|---|
| Receipt number | R000060632 |
| Scientific Title | Effects of Togedokoro intake on athlete's condition : Pilot study |
| Date of disclosure of the study information | 2023/12/16 |
| Last modified on | 2023/12/16 17:08:24 |
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Basic information
Public title
Preliminary investigation (pilot study) of the physical and psychological effects of Togedokoro foods on athletes of various sports, ages, and genders.
Acronym
Preliminary investigation (pilot study) of the physical and psychological effects of Togedokoro foods on athletes of various sports, ages, and genders.
Scientific Title
Effects of Togedokoro intake on athlete's condition : Pilot study
Scientific Title:Acronym
Effects of Togedokoro intake on athlete's condition : Pilot study
Region
| Japan |
Condition
Condition
Healthy male/female adults athletes
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the physical and psychological effects of Togedokoro foods on athletes of various sports, ages, and genders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Sex steroid hormone (saliva/ELISA) : dehydroepiandrosterone(DHEA), dehydroepiandrosterone sulfate(DHEA-S),testosterone, immune igA, cortisol.
Key secondary outcomes
1.Sleep and heart rate evaluation
2.Body composition (impedance method)
3.Physical fitness evaluation
4.Stress and fatigue questionnaire : The Profile of Mood States Second Edition (Japanese short ver.),visual analog scale, Diagnostic Inventory of Psychological State Before Competition.
5.Sleep questionnaire : OSA sleep inventory MA version
6.Intestinal environment evaluation : frequency of defecation, bowel movement Bristol scale, intestinal flora test.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Period with Togedokoro food intake
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Athletes who are currently active as athletes
2) Have received an explanation of the test and fully understand its contents.
Key exclusion criteria
1) Athletes who are currently in a hospital, on medication, or otherwise receiving treatment
2) Athletes who are currently participating in another clinical trial, or who have participated in a clinical trial in the past and for whom more than one month has not passed since the last dose of that investigational drug
3) Women who are pregnant or potentially pregnant, women who are breastfeeding, or men or women who do not consent to contraception during the study
4) Other research subjects who are deemed by the principal investigator or subinvestigator or others to be unsuitable for the safe conduct of the study
5) Subjects who have food allergies to Togedokoro or yam.
6) Persons who are unable to swallow the supplements.
7) Persons who Togedokoro yams and yam on a daily basis.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuuya |
| Middle name | |
| Last name | Maritani |
Organization
Biolia.ink
Division name
Representative of Director
Zip code
212-0031
Address
2-1-625 Shinkokura, Saiwai-ku, Kawasaki City, Kanagawa Prefecture
TEL
090-4020-8011
support@biolia.co.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Tezuka |
Organization
Biolia.ink
Division name
Research Team
Zip code
154-0002
Address
1-48-3 Shimouma,Setagaya-ku,Tokyo
TEL
080-2075-4756
Homepage URL
yuya.tezuka@biolia.co.jp
Sponsor or person
Institute
Biolia.ink
Institute
Department
Personal name
Funding Source
Organization
Okinawa Television Development .ink
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2023 | Year | 12 | Month | 16 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 11 | 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
| 2023 | Year | 12 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060632
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| Registered date | File name |
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