UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055255 |
|---|---|
| Receipt number | R000063100 |
| Scientific Title | Effects of high carbohydrate gummi consumption on performance related to Golf 3 |
| Date of disclosure of the study information | 2024/09/09 |
| Last modified on | 2025/02/16 06:02:05 |
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Basic information
Public title
Effects of high carbohydrate gummi consumption on performance related to Golf 3
Acronym
Effects of high carbohydrate gummi consumption on performance related to Golf 3
Scientific Title
Effects of high carbohydrate gummi consumption on performance related to Golf 3
Scientific Title:Acronym
Effects of high carbohydrate gummi consumption on performance related to Golf 3
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of continuous consumption of high-sugar gummies during a round of golf on golf performance and fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue substances (salivary cortisol, salivary testosterone, T/C ratio, MHPG)
Key secondary outcomes
Interstitial glucose concentration
Golf performance (score, driver accuracy, iron accuracy and approach success rate)
Subjective assessment (relaxation, concentration, fatigue, sleepiness during play)
Stress assessment (HF, LH/HF)
Sleep assessment (aMT6s)
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
High-carbohydrate gummies
Interventions/Control_2
Placebo gummies
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
| Not applicable |
Gender
Male
Key inclusion criteria
The participant criteria were as follows: (1) consume healthy foods, were nonsmokers, (2) in FY2023, if the highest result was below the local competition, not a national competitor, and (3) any bone or joint problems (e.g., back, knee or hip) that might limit your ability to play.
Key exclusion criteria
The following are excluded
Persons who are allergic to any of the foods tested.
Those taking medications or dietary supplements that may affect blood glucose levels.
Persons deemed ineligible at the discretion of the principal investigator.
Target sample size
24
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 and Life Sciences
Zip code
3550154
Address
111-1, Minami Yoshimi, Yoshimi-Town, Hiki-Gun, Saitama Pref.
TEL
0493545101
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 and Life Sciences
Zip code
3550154
Address
111-1, Minami Yoshimi, Yoshimi-Town, Hiki-Gun, Saitama Pref.
TEL
0493545101
Homepage URL
nagashima-y@musashigaoka.ac.jp
Sponsor or person
Institute
Department of Health Science, Musashigaoka Junior College
NAGASHIMA Yosuke
Institute
Department
Personal name
Funding Source
Organization
Bourbon Corporation
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
Musashigaoka Junior College
Address
111-1, Minami Yoshimi, Yoshimi-Town, Hiki-Gun, Saitama Pref.
Tel
0493545101
nagashima-y@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 09 | 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
23
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
| 2024 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063100
