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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033042
Receipt No. R000037663
Scientific Title A randomized, non-eating-controlled crossover study to investigate the relief effect of chicken meat on muscle fatigue.
Date of disclosure of the study information 2018/06/19
Last modified on 2018/09/11

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Basic information
Public title A randomized, non-eating-controlled crossover study to investigate the relief effect of chicken meat on muscle fatigue.
Acronym The trial for investigation of anti-fatigue effect of chicken meat.
Scientific Title A randomized, non-eating-controlled crossover study to investigate the relief effect of chicken meat on muscle fatigue.
Scientific Title:Acronym The trial for investigation of anti-fatigue effect of chicken meat.
Region
Japan

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

Objectives
Narrative objectives1 To investigate the relief effect of muscle fatigue associated with ingestion of chicken meat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of the serum CPK level from pre-exercise
Key secondary outcomes 1. Serum CPK level
2. Visual analogue scale
3. Total exercise duration and change of exercise duration from pre-exercise
4. Fatigue related biochemical examination of blood
5. Adverse event

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The subjects take 100g test food (chicken meat(salad chicken)) before exercise.
Interventions/Control_2 The subjects don't take test food.
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
20 years-old <=
Age-upper limit
39 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria 1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases on self-reported health questionnaire.
2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
3. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
4. Subjects who are heavy smoker (more than 21 cigarettes per day) and alcohol addicts (more than 80 g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency.
5. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
6. Pregnant or lactating women or women expect to be pregnant during this study.
7. Subjects who have cognitive disorder or who have possibility of the disorder.
8. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study.
9. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuji Arimura
Organization University of Miyazaki
Division name Clinical research support center, university of Miyazaki hospital
Zip code
Address Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL 0985-85-9577
Email yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuji Arimura
Organization University of Miyazaki
Division name Clinical research support center, university of Miyazaki hospital
Zip code
Address Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL 0985-85-9577
Homepage URL
Email yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization Miyazaki Prefecture
Organization
Division
Category of Funding Organization Local Government
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
2018 Year 06 Month 19 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 No longer recruiting
Date of protocol fixation
2018 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
2018 Year 07 Month 25 Day
Date of closure to data entry
2018 Year 08 Month 31 Day
Date trial data considered complete
2018 Year 09 Month 11 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 18 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037663

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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