UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062645 |
|---|---|
| Receipt number | R000071706 |
| Scientific Title | Effects of pre-exercise protein ingestion on performance and executive function |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/21 11:21:05 |
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Basic information
Public title
Effects of pre-exercise protein ingestion on performance and executive function
Acronym
Effects of pre-exercise protein ingestion on performance and executive function
Scientific Title
Effects of pre-exercise protein ingestion on performance and executive function
Scientific Title:Acronym
Effects of pre-exercise protein ingestion on performance and executive function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of pre-exercise protein ingestion on performance in resistance and endurance exercise, and on executive function after exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study 1: total number of repetitions across five sets of leg press performed to volitional failure at 70% of one-repetition maximum. Study 2: time to exhaustion during incremental cycling exercise.
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A single dose of whey protein (SAVAS Aqua Whey Protein 100, Meiji Co., Ltd.) equivalent to 0.4 g of protein per kilogram of body weight (approximately 0.56 g of powder per kilogram, up to a maximum of 56 g of powder per dose), dissolved in 400 mL of water, is ingested 60 minutes before exercise. The exercise task starts 60 minutes after ingestion.
Interventions/Control_2
Only 400 mL of water is ingested 60 minutes before exercise. The same exercise task as in the protein arm starts 60 minutes after ingestion. The two conditions are administered in a randomized crossover order, with an interval of at least one week between conditions.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults affiliated with Niigata University of Health and Welfare. Aged 18 to 30 years. Both sexes are eligible. Not restricted from exercising by a physician. Provided written informed consent after receiving an explanation of the study.
Key exclusion criteria
Individuals in poor physical condition (fever of 38 or higher, marked palpitations, shortness of breath, severe fatigue, or cold sweat). Individuals diagnosed at a health checkup with hypertension (resting blood pressure of 180/110 mmHg or higher), heart disease, or an infectious disease. Individuals with a history of cardiovascular disease, an orthopedic or neurological disorder requiring exercise restriction, or a serious medical condition currently under treatment, or who have been advised by a physician to restrict exercise. Individuals with an allergy to milk, dairy products, or soy. Individuals with a history of kidney disease. Individuals who habitually take protein supplements. Individuals with color vision deficiency.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Genta |
| Middle name | |
| Last name | Ochi |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences, Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-City
TEL
025-257-4595
ochi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Genta |
| Middle name | |
| Last name | Ochi |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences, Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-City
TEL
025-257-4595
Homepage URL
ochi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-City
Tel
025-257-4455
rinri@nuhw.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 | 08 | Month | 21 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2026 | Year | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071706
