UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037938 |
|---|---|
| Receipt number | R000043249 |
| Scientific Title | The effect of intake of caffeine and amino acid in the morning on biological rhythm and social jet lag. |
| Date of disclosure of the study information | 2019/09/05 |
| Last modified on | 2021/09/06 12:15:27 |
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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
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
hk.kim@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043249
