UMIN-CTR Clinical Trial

Basic information
Public title	The effect of intake of caffeine and amino acid in the morning on biological rhythm and social jet lag.
Acronym	The effect of intake of caffeine and amino acid in the morning on biological rhythm and social jet lag.
Scientific Title	The effect of intake of caffeine and amino acid in the morning on biological rhythm and social jet lag.
Scientific Title:Acronym	The effect of intake of caffeine and amino acid in the morning on biological rhythm and social jet lag.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate the effect of intake of caffeine and amino acid in the morning on biological rhythm and social jet lag.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following measures would be conducted before and after 2 weeks of intervention. 1) clock gene and social jet lag.
Key secondary outcomes	1) 24-hour glucose level 2) physical activity(accelerometer) 3) sleep evaluation (Sleep measurement device) 4) morningness-eveningness type, Pittsburgh sleep quality index, food frequency questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	7
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food A for 1 week.
Interventions/Control_2	Intake of test food B for 1 week.
Interventions/Control_3	Intake of test food C for 1 week.
Interventions/Control_4	Intake of test food D for 1 week.
Interventions/Control_5	Intake of test food E for 1 week.
Interventions/Control_6	Intake of test food F for 1 week.
Interventions/Control_7	Control Group
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)Gives informed consent, agrees to be randomly assigned
Key exclusion criteria	1) Physically active lifestyle 2) Intake of lipid and/or glucose lowering medication 3) Intake of Antipsychotics, Hypnotic, Steroids 4) Xylocaine allergy 5) Judged ineligible by a medical doctor. 6) Obesity (BMI>35kg/m2) and sleep apnea syndrome 7) High blood pressure (SBP: above 140mmHg, and DBP: above 90mmHg)
Target sample size	105

Research contact person
Name of lead principal investigator	1st name Shigenobu Middle name Last name Shibata
Organization	Waseda University
Division name	Faculty of Science and Engineering
Zip code	162-8480
Address	2-2 Wakamatsu, Shinjuku, Tokyo
TEL	03-5369-7318
Email	shibatas@waseda.jp

Public contact
Name of contact person	1st name Hyeon-Ki Middle name Last name Kim
Organization	Waseda University
Division name	School of Advanced Science and Engineering
Zip code	162-8480
Address	2-2 Wakamatsu, Shinjuku, Tokyo
TEL	03-5369-7318
Homepage URL
Email	hk.kim@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	NOEVIR Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	NOEVIR Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Waseda University
Address	1-104 Totsuka, Shinjuku, 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	2019 Year 09 Month 05 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	2019 Year 06 Month 24 Day
Date of IRB	2019 Year 09 Month 05 Day
Anticipated trial start date	2019 Year 09 Month 17 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 05 Day
Last modified on	2021 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043249