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

Email

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


Email

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

Email

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