UMIN-CTR Clinical Trial

Public title

The effect of amino acid ingestion on biological clock - placebo controlled, randomized, double-blind, cross-over study -

Acronym

The effect of amino acid ingestion on biological clock

Scientific Title

The effect of amino acid ingestion on biological clock - placebo controlled, randomized, double-blind, cross-over study -

Scientific Title:Acronym

The effect of amino acid ingestion on biological clock

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of the repeated ingestion of amino acid on biological rhythm in human

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Melatonin concentration in saliva

Key secondary outcomes

Cortisol concentration in saliva

Study type

Interventional

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

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of amino acid (400 mg/day) for 7 days

Interventions/Control_2

Ingestion of placebo for 7 days

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Subject received an explanation for this study and gave written informed consent.
(2) Subject is healthy and has no chronic disease.
(3) Melatonin in saliva can be detectable.
(4) Subject must be admitted to this study by the supervisor doctor.

Key exclusion criteria

(1) Subject receives treatment, or always uses medicines or quasi-drugs.
(2) Subject is expected to use medicine during this study.
(3) Subject is or has been serious diseases, thyroid gland disease, adrenal gland disease, or metabolic disorder.
(4) Subject is or has been diseases related to sleep.
(5) Subject has been diagnosed with xerostomia or has xerostomia symptoms.
(6) Subject is or has been diagnosed with the drug or alchol dependence.
(7) Subject has the possibility of drug and/or food allergy.
(8) Subject is predict to occurred to have life events, which may affect their mental conditions, during this study.
(9) Subject has a plan to participate in other study during this study.
(10) Subject or his/her family work for a company on manufacturing or selling health foods or foods with function claims.
(11) Subject can not sleep during night because of shift work or other reasons.
(12) His/her native language is not Japanese.
(13) Subject is judged as unsuitable for the study by pre test questionnaire.
(14) Subject has a plan to become pregnant during the current study or are pregnant or lactating.
(15) Subject has a considerable difference in results of motion sensor and pre-questionaires.
(16) Subject has values significantly deviated from the reference range in body measurement values declared beforehand
(17) Subject is judged inadequateness on this study by subject background questionnaire.
(18) Subject has a plan to travel abroad during two weeks before this study starts and during this study.
(19) Subject usually consumes food with functional claims and/or supplement which may affect melatonin secretion.
(20) Subject is restricted intake of amino acid because he/she has been diagnosed with genetically deficient in metabolic enzyme.
(21) Subject is judged inadequateness on this study by the supervisor doctor.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Shigenobu Shibata

Organization

Waseda University

Division name

Faculty of Science and Engineering

Zip code

Address

2-2 Wakamatsu-cho, Shinjuku-ku, Tokyo, 162-8480, Japan

TEL

+81-3-5369-7318

Email

shibatas@waseda.jp

Name of contact person

1st name
Middle name
Last name	Atsushi Haraguchi

Organization

Waseda University

Division name

Graduate School of Advanced Science and Engineering

Zip code

Address

2-2 Wakamatsu-cho, Shinjuku-ku, Tokyo, 162-8480, Japan

TEL

+81-3-5369-7318

Homepage URL

Email

hmar.h@fuji.waseda.jp

Institute

Waseda University

Institute

Department

Personal name

Organization

Kirin Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Waseda University

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

早稲田大学

Date of disclosure of the study information

2017

Year

03

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2017

Year

03

Month

28

Day

Date of IRB

Anticipated trial start date

2017

Year

04

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

28

Day

Last modified on

2017

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030699