UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026421 |
|---|---|
| Receipt number | R000030353 |
| Scientific Title | The effects of imidazole dipeptide supplementation on sleep and performance |
| Date of disclosure of the study information | 2017/03/06 |
| Last modified on | 2017/03/06 16:35:26 |
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Basic information
Public title
The effects of imidazole dipeptide supplementation on sleep and performance
Acronym
The effects of imidazole dipeptide supplementation on sleep and performance
Scientific Title
The effects of imidazole dipeptide supplementation on sleep and performance
Scientific Title:Acronym
The effects of imidazole dipeptide supplementation on sleep and performance
Region
| Japan |
Condition
Condition
Healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate the effects of imidazole dipeptide supplementation on sleep.
2. To investigate the effects of imidazole dipeptide supplementation on performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The present study is a balanced, randomized cross-over design with a 1-week intervening period.
We evaluate the following items at before and after intake of supplement.
Objective sleep quality
(i.e. sleep latency, sleep efficiency)
Subjective sleep quality
(questionnaire)
athletic performance for badminton skill
short service test (success rate)
travelling time in badminton court
Key secondary outcomes
Test for attention performance
Go/No-go task
Flexibility task
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Intake of imidazole dipeptide supplementation
1week intervention
0.5g*3(before breakfast,lunch,dinner)
1.5g/day
Interventions/Control_2
Intake of placebo
1week intervention
0.5g*3(before breakfast,lunch,dinner)
1.5g/day
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
1. BMI <28m2
2. 6 to 9 hours of sleep duration
3. Non smoker
4. They do not take excessive caffeine
5. Moderate morning or intermediate type
Key exclusion criteria
1. Sleeping hours differ for more than 45 minutes on weekdays and holidays
2. Turn off before 21 o'clock
3. Wake up after 9 o'clock
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Maeda |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-8859
maeda@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Nakamura |
Organization
University of Tsukuba
Division name
Major of sport medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-5600
Homepage URL
s1530397@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
NH Foods Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 03 | Month | 06 | 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 | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | 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 | 06 | Day |
Last modified on
| 2017 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030353
