UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of imidazole dipeptide supplementation on sleep and performance
Title of the study (Brief title)	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	Seiji Maeda
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-8859
Email	maeda@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	Yuki Nakamura
Organization	University of Tsukuba
Division name	Major of sport medicine
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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