UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035371 |
|---|---|
| Receipt number | R000040179 |
| Scientific Title | Effect of amino acids intake on post-exercise gastrointestinal function |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2022/10/23 13:11:46 |
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Basic information
Public title
Effect of amino acids intake on post-exercise gastrointestinal function
Acronym
Effect of amino acids intake on post-exercise gastrointestinal function
Scientific Title
Effect of amino acids intake on post-exercise gastrointestinal function
Scientific Title:Acronym
Effect of amino acids intake on post-exercise gastrointestinal function
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of amino acids intake on post-exercise gastrointestinal function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal function / Improvement
Key secondary outcomes
Inflammatory response / Improvement
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Amino acids intake
Exercise loading
Measurements of gastrointestinal function and inflammatory response
Three-weeks washout
Placebo intake
Exercise loading
Measurements of gastrointestinal function and inflammatory response
Interventions/Control_2
Placebo intake
Exercise loading
Measurements of gastrointestinal function and inflammatory response
Three-weeks washout
Amino acids intake
Exercise loading
Measurements of gastrointestinal function and inflammatory response
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy adult
2. A subject who can participate in exercise loading
3. A subject who can provide written informed consent
Key exclusion criteria
1. Any subject who has orthopedic diseases such as fractures or sprains
2. Any subject who has cardiovascular diseases such as heart disease or hypertension
3. Any subject who has a gastrointestinal disorder
4. Any subject who takes NSAIDs
5. Any subject who had 200 mL or more of blood taken within the past 12 weeks
6. Any subject who has a history of diabetes or blood sugar abnormality
7. Any subject who has a known allergy to food containing sugar alcohol or lactulose
8. Any subject who has galactosemia or lactose intolerance
9. Any subject who is considered as inappropriate for participating into the study at the judgment of principal investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa-shi, Saitama
TEL
04-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Ono |
Organization
Ajinomoto Co., Inc
Division name
Human health & nutrition group, Institute of food sciences & technologies
Zip code
210-0801
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi
TEL
044-223-4114
Homepage URL
miho_ono@ajinomoto.com
Sponsor or person
Institute
Waseda University, Faculty of Sport Sciences
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
Totsuka-cho, shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
早稲田大学（埼玉県）/ Waseda University
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 01 | 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
16
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
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2018 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040179
