UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062939 |
|---|---|
| Receipt number | R000072061 |
| Scientific Title | Development of a Simple Method for Estimating Lactate Threshold under Conditions of Elevated Blood Glucose and Lactate Concentrations |
| Date of disclosure of the study information | 2026/09/15 |
| Last modified on | 2026/09/15 22:34:32 |
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Basic information
Public title
Development of a Simple Method for Estimating Lactate Threshold under Conditions of Elevated Blood Glucose and Lactate Concentrations
Acronym
Simple Method for Estimating Lactate Threshold
Scientific Title
Development of a Simple Method for Estimating Lactate Threshold under Conditions of Elevated Blood Glucose and Lactate Concentrations
Scientific Title:Acronym
Simple LT Estimation
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a simple method for determining the lactate threshold under conditions of elevated blood glucose and blood lactate concentrations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in lactate threshold intensity between the simple estimation method and the conventional method.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Participants will consume mineral water followed by exercise.
Interventions/Control_2
Participants will consume a sports drink followed by exercise.
Interventions/Control_3
Participants will consume a glucose solution followed by exercise.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults without any medical conditions requiring treatment or restrictions on exercise.
Key exclusion criteria
Individuals with medical conditions requiring treatment or restrictions on exercise.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Tobina |
Organization
University of Nagasaki
Division name
Department of Nursing and Nutrition
Zip code
851-2195
Address
1-1-1, Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5200
tobitaku@sun.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Tobina |
Organization
University of Nagasaki
Division name
Department of Nursing and Nutrition
Zip code
851-2195
Address
1-1-1, Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
TEL
095-813-5200
Homepage URL
tobitaku@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
University of Nagasaki
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
University of Nagasaki
Address
1-1-1, Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki
Tel
095-813-5500
tobitaku@sun.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
| 2026 | Year | 09 | Month | 15 | 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
43
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
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 15 | Day |
Last modified on
| 2026 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072061
