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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034074 |
Receipt No. | R000038841 |
Scientific Title | Test on the influence of food intake on muscle degradation inhibitory effect during exercise |
Date of disclosure of the study information | 2018/09/10 |
Last modified on | 2019/03/11 |
Basic information | ||
Public title | Test on the influence of food intake on muscle degradation inhibitory effect during exercise | |
Acronym | Test on the influence of food intake on muscle degradation during exercise | |
Scientific Title | Test on the influence of food intake on muscle degradation inhibitory effect during exercise | |
Scientific Title:Acronym | Test on the influence of food intake on muscle degradation during exercise | |
Region |
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Condition | ||
Condition | Healthy Adults | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Explore the influence of food intake on muscle degradation inhibitory effect during exercise. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Blood urea nitrogen at the beginning of and after exercise |
Key secondary outcomes | General blood biochemical test (total protein, albumin, total cholesterol, blood neutral fat (TG), HDL-cholesterol, LDL-cholesterol, AST(GOT), ALT(GPT), ALP, gamma-GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium, phosphorus, LDH, HbA1c), Saliva test (urea nitrogen), physical examination (body weight, blood pressure, pulse rate, BMI, body fat percentage), questionnaire on lifestyle habit and on fatigue at the beginning of and after exercise, and maximal oxygen uptake |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Ingest total 234 g of banana before exercise | |
Interventions/Control_2 | none | |
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. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 20 years old or more and under 40 years old 3. Persons who have confidence to possess physical fitness to withstand exercise stress test |
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Key exclusion criteria | 1. Persons who have a chronic disease and is under medication, or has a serious disease history
2. Persons who are allergic to the test food 3. Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement 4. Persons who are judged inappropriate for the exam by the principal investigator 5. Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period 6. Persons who are prohibited from exercising by the doctor |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Healthcare Systems Co., Ltd. | ||||||
Division name | Research and Development | ||||||
Zip code | |||||||
Address | Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN | ||||||
TEL | 03-6809-2722 | ||||||
masudat@hc-sys.jp |
Public contact | |||||||
Name of contact person |
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Organization | Healthcare Systems Co., Ltd. | ||||||
Division name | Research and Development | ||||||
Zip code | |||||||
Address | Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN | ||||||
TEL | 03-6809-2722 | ||||||
Homepage URL | |||||||
masudat@hc-sys.jp |
Sponsor | |
Institute | Healthcare Systems Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | SOLROS Co., 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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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=R000038841 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |