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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033748 |
Receipt No. | R000038489 |
Scientific Title | A study to evaluate effects of test food on physical performance and fatigue during exercise |
Date of disclosure of the study information | 2018/09/12 |
Last modified on | 2019/02/13 |
Basic information | ||
Public title | A study to evaluate effects of test food on physical performance and fatigue during exercise | |
Acronym | A study to evaluate effects of test food on physical performance and fatigue during exercise | |
Scientific Title | A study to evaluate effects of test food on physical performance and fatigue during exercise | |
Scientific Title:Acronym | A study to evaluate effects of test food on physical performance and fatigue 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 | To evaluate effects of test food on physical exercise and fatigue. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Maximal oxygen consumption (VO2 max)
Questionnaire on fatigue |
Key secondary outcomes | Ventilation threshold
Rating of perceived exertion Physical performance Blood biochemistry Muscle mass Body fat mass Intestinal microbiome |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
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 | 3 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Intake 3 tablets of active food 1 daily for 9 weeks. | |
Interventions/Control_2 | Intake 3 tablets of active food 2 daily for 9 weeks. | |
Interventions/Control_3 | Intake 3 tablets of placebo food daily for 9 weeks. | |
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 | |||
Key inclusion criteria | 1)Males aged 20-49 years.
2)Subjects who have exercise habits once or twice a week. 3)Subjects who can continue with the exercise habits during test period. 4)Subjects who don't take prohibited foods such as dietary supplements for exercise and can keep it during test period. 5)Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent. |
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Key exclusion criteria | 1)Subjects who have consciousness of being constipation or diarrhea.
2)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, or digestive system. 3)Subjects who drink alcohol a lot. 4)Subjects who have extremely irregular dietary habits or life rhythm. 5)Subjects who have allergy to medicines or foods. 6)Subjects who are participating the other clinical test, were participating it within the past 4 weeks, or are going to participate it. 7)Subjects who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 8)Subjects judged as unsuitable for the study by the principal or attending investigator. |
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Target sample size | 36 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | CPCC Company Limited | ||||||
Division name | Clinical Research Planning Department | ||||||
Zip code | |||||||
Address | 4F Chushin Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo 101-0047, Japan | ||||||
TEL | 03-5297-3112 | ||||||
cpcc-contact@cpcc.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | CPCC Company Limited | ||||||
Division name | Plan Sales Department | ||||||
Zip code | |||||||
Address | 4F Chushin Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo 101-0047, Japan | ||||||
TEL | 03-5297-3112 | ||||||
Homepage URL | |||||||
cpcc-contact@cpcc.co.jp |
Sponsor | |
Institute | CPCC Company Limited |
Institute | |
Department |
Funding Source | |
Organization | Asahi Group Holdings, 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 | |||||||
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=R000038489 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |