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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy Volunteers | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | NH Foods Ltd.
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Division name | R&D Center | ||||||
Zip code | |||||||
Address | 3-3 Midorigahara, Tsukuba, Ibaraki | ||||||
TEL | 029-847-7815 | ||||||
m.satou@nipponham.co.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |