UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025374
Receipt number R000029215
Scientific Title The efficacy study of the amino acids on exercise performance and recovery
Date of disclosure of the study information 2021/12/22
Last modified on 2022/06/27 12:33:04

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Basic information

Public title

The efficacy study of the amino acids on exercise performance and recovery

Acronym

The efficacy study of the amino acids on exercise

Scientific Title

The efficacy study of the amino acids on exercise performance and recovery

Scientific Title:Acronym

The efficacy study of the amino acids on exercise

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the efficacy of the amino acids on exercise performance and recovery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Exercise performance / Recovery

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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Amino acids intake

Exercise load

Performance measurements

Amino acids intake 3 times a day, Recovery measurements

Wash out period (4 weeks)

Placebo intake

Exercise load

Performance measurements

Placebo intake 3 times a day, Recovery measurements

Interventions/Control_2

Placebo intake

Exercise load

Performance measurements

Placebo intake 3 times a day, Recovery measurements

Wash out period (4 weeks)

Amino acids intake

Exercise load

Performance measurements

Amino acids intake 3 times a day, Recovery measurements

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

30 years-old >=

Gender

Male

Key inclusion criteria

1. Healthy adults
2. A person who can take part in exercise load
3. A person who consented to take part in this study

Key exclusion criteria

1. A person who has an allergy for the ingredient of test food
2. A person who are being treated for inflammatory diseases and injuries
3. A person who has surgical injury or internal disease
4. A person who is judged inadequate to join this study by lead 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 Naoko
Middle name
Last name Fujimura

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

naoko_fujimura@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

1-104, Totsukamachi, Shinjyuku-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



Other administrative information

Date of disclosure of the study information

2021 Year 12 Month 22 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

Completed

Date of protocol fixation

2016 Year 12 Month 22 Day

Date of IRB

2016 Year 12 Month 21 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 22 Day

Last modified on

2022 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029215