UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047200 |
|---|---|
| Receipt number | R000053840 |
| Scientific Title | Research on the effects of ingestion of beverage containing amino acids on body fluid restoration after exercise dehydration |
| Date of disclosure of the study information | 2022/03/17 |
| Last modified on | 2025/04/01 11:21:39 |
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Basic information
Public title
Research on the effects of ingestion of beverage containing amino acids on body fluid restoration after exercise dehydration
Acronym
Research on the effects of ingestion of beverage containing amino acids on body fluid restoration after exercise dehydration
Scientific Title
Research on the effects of ingestion of beverage containing amino acids on body fluid restoration after exercise dehydration
Scientific Title:Acronym
Research on the effects of ingestion of beverage containing amino acids on body fluid restoration after exercise dehydration
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of ingestion of beverage containing amino acids on body fluid restoration after exercise dehydration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery of body fluid volume (calculated by subtracting the urine volume from the volume of fluid ingestion)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Water (control)
Interventions/Control_2
Water + electrolytes (Na+, K+, Ca2+, Mg2+)
Interventions/Control_3
Water + electrolytes (Na+, K+, Ca2+, Mg2+) + amino acids component
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Male
2. Age <= 20 years old to >= 39 years old at the time of informed consent
3. Volunteers who exercise regularly (>=30 min/day, >=2 times/week)
4. Volunteers who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study
Key exclusion criteria
1. Any medical problem for exercise restriction detected in the medical examination within 1 year
2. Cardiovascular diseases, arrhythmia, and past medical history of these diseases
3. Hypertension (resting blood pressure, SBP > or = 160 mmHg, DBP > or = 100)
4. Metabolic and endocrine disease
5. Renal disease
6. Smokers
7. Obesity (BIM >= 30 kg/m2)
8. Blood donation >= 400 mL within 3 month before and after the participation
9. Allergy (wheat, egg, milk, almond, soybean, apple, gelatin)
10. Ineligible by a medical interview
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka
TEL
06-6605-2950
okazaki@osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunobu |
| Middle name | |
| Last name | Kazunobu |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka
TEL
06-6605-2950
Homepage URL
okazaki@osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
COCA-COLA (Japan) COMPANY
AJINOMOTO CO.
AJINOMOTO HEALTHY SUPPLY CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University
Address
1-4-3 Asahi-machi, Abeno, Osaka
Tel
06-6645-3457
ethics@med.osaka-cu.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
| 2022 | Year | 03 | Month | 17 | 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
10
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
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053840
