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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033892
Receipt No. R000038656
Scientific Title A clinical study to evaluate the effects of imidazole dipeptides on improving fatigue sensation
Date of disclosure of the study information 2019/12/02
Last modified on 2018/08/25

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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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