UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026740
Receipt No. R000030699
Scientific Title The effect of amino acid ingestion on biological clock - placebo controlled, randomized, double-blind, cross-over study -
Date of disclosure of the study information 2017/03/28
Last modified on 2017/09/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Melatonin concentration in saliva
Key secondary outcomes Cortisol concentration in saliva

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 No need to know

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Kirin Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Waseda University

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 28 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 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
Other related information

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2017 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.