UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052039 |
|---|---|
| Receipt number | R000059395 |
| Scientific Title | The effect of consuming high carbohydrate gummies on golf performance |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2024/02/28 09:17:13 |
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Basic information
Public title
The effect of consuming high carbohydrate gummies on golf performance
Acronym
The effect of consuming high carbohydrate gummies on golf performance
Scientific Title
The effect of consuming high carbohydrate gummies on golf performance
Scientific Title:Acronym
The effect of consuming high carbohydrate gummies on golf performance
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consumption of high carbohydrate gummies on golf performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Golf Performance (Score, Number of putts, Driving accuracy, Iron Accuracy, Recovery success rate)
Interstitial glucose
Subjective Rating Scales(fatigue, relaxation, and concentration)
Urinary muscle damage marker
Key secondary outcomes
Anxiety Tests
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
High carbohydrate-containing gummies 1
Interventions/Control_2
High carbohydrate-containing gummies 2
Interventions/Control_3
Carbohydrate-containing gummies
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
| Not applicable |
Gender
Male
Key inclusion criteria
1.A male athlete in the A and B leagues of the Kanto University Golf Federation.
2.Subjects giving written informed consent.
Key exclusion criteria
1.Subject who are allergic to gelatin.
2.Allergic to shrimp, crab, walnuts, wheat, buckwheat, eggs, milk, peanuts (peanuts)
3.Subject who tekes health foods such as pharmaceuticals and supplements that may affect blood glucose response.
4.Smoker.
5.Subject tho has been judded by the investigator to be inappro priate to participate in this study/
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nagashima |
Organization
Musashigaoka Junior College
Division name
Department of Health Science
Zip code
355-0154
Address
111-1 Minamiyoshimi, Yoshimi-cho, Hiki-gun, Saitama
TEL
0493-54-51.1
nagashima-y@musashigaoka.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nagashima |
Organization
Musashigaoka Junior College
Division name
Department of Health Science
Zip code
355-0154
Address
111-1 Minamiyoshimi, Yoshimi-cho, Hiki-gun, Saitama
TEL
0493-54-5101
Homepage URL
nagashima-y@musashigaoka.ac.jp
Sponsor or person
Institute
Musashigaoka Junior College
Institute
Department
Personal name
Yosuke Nagashima
Funding Source
Organization
Bourbon 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
The ethics Committee of Musashioka Junior College, Japan
Address
111-1 Minamiyoshimi, Yoshimi-cho, Hiki-gun, Saitama
Tel
0493-54-5101
info@musashigaoka.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
青梅ゴルフ倶楽部（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 30 | 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
29
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
| 2023 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059395
