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

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 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


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

Value
https://center6.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