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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026421
Receipt No. 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

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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
Email 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
Email s1530397@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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