UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063058 |
|---|---|
| Receipt number | R000072188 |
| Scientific Title | Effects of Early Time-Restrieted Eating on Body Composition, Muscle Damage Biomarkers, and Metabolic and Hepatic Biomarkers in Young Karate Athletes |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/26 10:22:53 |
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Basic information
Public title
Effects of Early Time-Restrieted Eating on Body Composition, Muscle Damage
Biomarkers, and Metabolic and Hepatic Biomarkers in Young Karate Athletes
Acronym
Effects of Early Time-Restrieted Eating
Scientific Title
Effects of Early Time-Restrieted Eating on Body Composition, Muscle Damage
Biomarkers, and Metabolic and Hepatic Biomarkers in Young Karate Athletes
Scientific Title:Acronym
Effects of Early Time-Restrieted Eating
Region
| Asia(except Japan) |
Condition
Condition
none
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study was to evaluate the effect of e-TRE on Body Composition, Muscle Damage Biomarkers, and Metabolic and Hepatic Biomarkers in Young Karate Athletes.
Basic objectives2
Others
Basic objectives -Others
to evaluate the effect of e-TRE on Body Composition, Muscle Damage Biomarkers, and Metabolic and Hepatic Biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body Composition, and Circulating Biomarkers of Muscle Damage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Early Time-Restricted Eating (e-TRE) Group (n=25)
Interventions/Control_2
Control Group (n=25)
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
| 19 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
19-25 years old
karate players
Key exclusion criteria
not diseased
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Maha |
| Middle name | |
| Last name | Gasmi |
Organization
1Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.
Division name
1Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.
Zip code
NA
Address
Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.
TEL
000
mahagasmi@hotmail.fr
Public contact
Name of contact person
| 1st name | Maha |
| Middle name | |
| Last name | Gasmi |
Organization
1Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.
Division name
1Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.
Zip code
NA
Address
1Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.
TEL
000
Homepage URL
mahagasmi@hotmail.fr
Sponsor or person
Institute
1Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Higher Institute of Sport and Physical Education of Ksar Said Manouba University
Address
Higher Institute of Sport and Physical Education of Ksar Said Manouba University
Tel
71 548 432 / 71544 630
Higher Institute of Sport and Physical Education of Ksar Said Manouba University
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 | 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
50
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
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 01 | 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 | 26 | Day |
Last modified on
| 2026 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072188
