UMIN-CTR Clinical Trial

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
Email	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
Email	miho_ono@ajinomoto.com

Sponsor
Institute	Waseda University, Faculty of Sport Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040179