UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021285 |
|---|---|
| Receipt number | R000024551 |
| Scientific Title | The randomized double blind cross-over test of the effect of citric acid intake on physical fatigue after exercise |
| Date of disclosure of the study information | 2016/03/03 |
| Last modified on | 2019/03/05 10:19:24 |
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Basic information
Public title
The randomized double blind cross-over test of the effect of citric acid intake on physical fatigue after exercise
Acronym
The test of the effect of citric acid intake on physical fatigue after exercise
Scientific Title
The randomized double blind cross-over test of the effect of citric acid intake on physical fatigue after exercise
Scientific Title:Acronym
The test of the effect of citric acid intake on physical fatigue after exercise
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of citric acid intake on physical fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood lactic acid, glucose, NK cell activity, IL-6 before or after exercise, Visual analog scale for fatigue
Key secondary outcomes
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
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of Test sample A (containing high citric acid) before exercise >> wash out period (at least3 day) >> Intake of Test sample B (containing low citric acid) before exercise >> wash out period (at least3 day) >> Intake of placebo before exercise >> wash out period (at least3 day) >>
Intake of Test sample A (containing high citric acid) after exercise >> wash out period (at least3 day) >> Intake of Test sample B (containing low citric acid) after exercise >> wash out period (at least3 day) >> Intake of placebo after exercise
The subjects carry out exercise by using cycle ergometer for 15 min at 50 % of maximum exercise intensity and for 20 min at 70 % of maximum exercise intensity.
Interventions/Control_2
Intake of Test sample B before exercise >> wash out period (at least3 day) >> Intake of placebo before exercise >> wash out period (at least3 day) >> Intake of Test sample A before exercise >> wash out period (at least3 day) >>
Intake of Test sample B after exercise >> wash out period (at least3 day) >> Intake of placebo after exercise >> wash out period (at least3 day) >> Intake of Test sample A after exercise
The subjects carry out exercise by using cycle ergometer for 15 min at 50 % of maximum exercise intensity and for 20 min at 70 % of maximum exercise intensity.
Interventions/Control_3
Intake of placebo before exercise >> wash out period (at least3 day) >> Intake of Test sample A before exercise >> wash out period (at least3 day) >> Intake of Test sample B before exercise >> wash out period (at least3 day) >>
Intake of placebo after exercise >> wash out period (at least3 day) >> Intake of Test sample A after exercise >> wash out period (at least3 day) >> Intake of Test sample B after exercise
The subjects carry out exercise by using cycle ergometer for 15 min at 50 % of maximum exercise intensity and for 20 min at 70 % of maximum exercise intensity.
Interventions/Control_4
Intake of Test sample B (containing low citric acid) before exercise >> wash out period (at least 7 day) >> Intake of placebo before exercise
The subjects carry out exercise by using cycle ergometer for 15 min at 50 watt exercise intensity and for 20 min at 70 watt exercise intensity.
Interventions/Control_5
Intake of placebo before exercise >> wash out period (at least 7 day) >> Intake of Test sample B (containing low citric acid) before exercise
The subjects carry out exercise by using cycle ergometer for 15 min at 50 watt exercise intensity and for 20 min at 70 watt exercise intensity.
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1. Healthy subjects
2. Person who provides informed consent by a document.
3. Students of Osaka Kawasaki Rehabilitation University
Key exclusion criteria
1. Subjects who daily take Ume and carbonated drink
2. Subjects who have diastolic blood pressure over 90 mmHg
3. Subjects who have food allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misa Nakamura |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
Address
Mizuma 158, Kaizuka City, Osaka 597-0104, Japan
TEL
072-446-6700
nakamuram@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Utsunomiya |
Organization
Wakayama Medical University
Division name
Department of Strategic Surveillance for Functional Food and Comprehensive Traditional Medicine
Zip code
Address
Kimiidera 811-1, Wakayama City, Wakayama 641-0012, Japan
TEL
073-447-2300
Homepage URL
utsu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Minabe-cho, Hidaka-gun, Wakayama prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
| 2016 | Year | 03 | Month | 03 | 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
Date of protocol fixation
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 03 | Day |
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
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024551
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