UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033717 |
|---|---|
| Receipt number | R000038447 |
| Scientific Title | Effects of Chinese massage combined with soy milk supplement on the recovery of exercise fatigue and exercise performance |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2019/10/05 14:53:02 |
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Basic information
Public title
Effects of Chinese massage combined with soy milk supplement on the recovery of exercise fatigue and exercise performance
Acronym
Effects of Chinese massage plus soy milk supplementation on post-exercise recovery
Scientific Title
Effects of Chinese massage combined with soy milk supplement on the recovery of exercise fatigue and exercise performance
Scientific Title:Acronym
Effects of Chinese massage plus soy milk supplementation on post-exercise recovery
Region
| Asia(except Japan) |
Condition
Condition
The healthy adults who routinely take exercise.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical benefits, such as post-exercise recovery and anti-fatigue effects, associated with ingestion of sugar-added soy milk beverage for the healthy adult with routinely take exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
5-km cycling time-trial test by bicycle ergometer at before main-exercise (15-km self-paced cycling exercise) and the next day.
Key secondary outcomes
1. Fatigue related scales (VAS, modified Borg scale)
2. Fatigue related biochemical examination of blood
3. Cognition related task performance
(They are assessed at before main-exercise (15-km self-paced cycling exercise) and the next day.)
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects are instructed to take commercially available sugar-added soy milk beverage at the time of immediately after the main-exercise (300 ml) and after the completion of post-exercise Chinese massage intervention (at one-hour after the main-exercise; 300 ml).
Interventions/Control_2
The subjects are instructed to take artificial sweeten pure water at the time of immediately after the main-exercise (300 ml) and after the completion of post-exercise Chinese massage intervention (at one-hour after the main-exercise; 300 ml).
Interventions/Control_3
The subjects are instructed to take artificial sweeten pure water at the time of immediately after the main-exercise (300 ml) and at one-hour after the main-exercise (300 ml). [Chinese massage intervention].
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who routinely take exercise.
3. Subjects who have no clinical skeletomuscular problems within 12-weeks prior to the study.
4. 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 with respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who can't take exercise tolerance by bicycle ergometer.
3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
4. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
5. Subjects who have cognitive disorder or who have possibility of the disorder.
6. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yi-Hung |
| Middle name | |
| Last name | Liao |
Organization
National Taipei University of Nursing and Health Sciences
Division name
Department of Exercise and Health Science
Zip code
11219
Address
No.365, Ming-Te Road, Peitou District,, Taipei City
TEL
+886228227101
yihungliao.henry@gmail.com
Public contact
Name of contact person
| 1st name | Yi-Hung |
| Middle name | |
| Last name | Liao |
Organization
National Taipei University of Nursing and Health Sciences
Division name
Department of Exercise and Health Science
Zip code
11219
Address
No.365, Ming-Te Road, Peitou District,
TEL
+886228227101
Homepage URL
yihungliao.henry@gmail.com
Sponsor or person
Institute
National Taipei University of Nursing and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fu Jen Catholic University
Address
No.510, Zhongzheng Rd., Xinzhuang Dist., New Taipei City 24205, Taiwan
Tel
02-2905-6277
irb@mail.fju.edu.tw
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
National Taipei University of Nursing and Health Sciences (Taipei City, Taiwan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 10 | 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
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
The study enrolled 11 participants signed informed consents, and one participant decided not to participate due to his personal reason for the difficulty about test schedule. Finally, ten subjects completed all three tests, and one participant did not comply the requirements of study control and was excluded from the study. Finally, nine participants were included in the data analyses. All subjects had reported no adverse responses during the trial.
Adverse events
All participants had no reports of adverse responses during all trials.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 28 | Day |
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 | 10 | Day |
Last modified on
| 2019 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038447
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