UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation
Acronym	A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation
Scientific Title	A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation
Scientific Title:Acronym	A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation
Region	Japan

Condition
Condition	Healthy Volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of imidazole dipeptides on improving fatigue sensation: a randomized, double-blind, placebo-controlled, crossover study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS (fatigue sensation)
Key secondary outcomes	Chalder fatigue scale, T score of "fatigue-inertia" in subscale of POMS2 short version, Performance test (10-second high power test) after 4-week intake

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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food for 4 weeks -> Washout for 4 weeks -> Intake of Placebo for 4 weeks
Interventions/Control_2	Intake of Placebo for 4 weeks -> Washout for 4 weeks -> Intake of test food for 4 weeks
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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects whose age of 40 years or more and less than 65 years 2) Subjects who were evaluated 40 or more in T score of "fatigue-inertia" in subscale of POMS2 short version 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Key exclusion criteria	1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects having the chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator 3) Subjects having a medical history of chest pain or syncope 4) Subjects deemed unsuitable in the electrocardiogram by the investigator 5) Subjects having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations 6) Subjects who have the possibility of developing allergic symptoms by the test food 7) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue 8) Subjects who take regularly supplements of protein or amino acid drink 9) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 10) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 11) Subjects who took part in another clinical study within 1 month prior to the start of the present study or who is currently taking part in another clinical study 12) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 13) Subjects deemed unsuitable by the investigator
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mikako Sato
Organization	NH Foods Ltd.
Division name	R&D Center
Zip code
Address	3-3 Midorigahara, Tsukuba, Ibaraki
TEL	029-847-7815
Email	m.satou@nipponham.co.jp

Public contact
Name of contact person	1st name Middle name Last name Tomohiro Sugino
Organization	Soiken Inc.
Division name	Representative Director
Zip code
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	NH Foods Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2019 Year 12 Month 02 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	Preinitiation
Date of protocol fixation	2018 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date	2018 Year 08 Month 25 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	2018 Year 08 Month 25 Day
Last modified on	2018 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038656

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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