UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046074 |
|---|---|
| Receipt number | R000052587 |
| Scientific Title | A study to examine the effect of post-exercise beverage intake on fatigue in exercisers, randomized placebo-controlled crossover study |
| Date of disclosure of the study information | 2021/11/22 |
| Last modified on | 2022/11/16 14:41:12 |
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Basic information
Public title
A study of the effect of post-exercise beverage intake on fatigue
Acronym
A study of the effect of post-exercise beverage intake on fatigue
Scientific Title
A study to examine the effect of post-exercise beverage intake on fatigue in exercisers, randomized placebo-controlled crossover study
Scientific Title:Acronym
A study to examine the effect of post-exercise beverage intake on fatigue
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of post-exercise beverage intake on physical sensation (fatigue) and exercise performance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective questionnaire assessment (VAS)
Key secondary outcomes
Exercise performance test (Wingate Test)
Blood lactate concentration
Blood glucose level
Rate of Perceived Exertion (RPE)
Heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Lactic acid (7.5g) containing beverage,
single dose
Interventions/Control_2
Placebo beverage,
single dose
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) More than 20 years and less than 60 years old
2) Subjects who habitually exercise to the extent that they can breathe at least once a week
3) Subjects who feel low elasticity after exercise, or who experience fatigue, muscle aches, leg cramps, etc. by the day after exercise.
4) Subjects who can use the bicycle ergometer
Key exclusion criteria
1) Subjects taking medicines, foods with functional claims, or foods for specified health use that may affect fatigue, muscle fatigue, or exercise performance
2) Subjects who are under medical treatment of diseases in liver, kidneys, heart, lungs, digestive system, blood, endocrine and metabolic systems, or who have serious medical history of those diseases
3) Subjects with chronic fatigue syndrome
4) Subjects with drug allergies or severe food allergies
5) Subjects who are pregnant, breastfeeding, or willing to become pregnant during the study
6) Subjects who collected 400 mL or more (including blood donation)within 12 weeks before the study, or who collected 200 mL or more of blood within 2 weeks before the study
7) Subjects with systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher
8) Subjects who are judged inappropriate for the study by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Saito |
Organization
Medical corporation
Shinanokai Samoncho Clinic
Division name
Internal Medicine
Zip code
160-0017
Address
6F Yotsuya Medical Bldg, 20 Samoncho, shinjuku-ku, Tokyo, JAPAN
TEL
03-5366-3641
pr-scl@shinanokai.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takaoka |
Organization
3H CTS Inc.
Division name
Sales manager
Zip code
171-0022
Address
1-13-23 Minamiikebukuro, Toshima-ku, Tokyo, JAPAN
TEL
03-6869-2920
Homepage URL
takaoka-ryosuke@3hcts.co.jp
Sponsor or person
Institute
Medical corporation
Shinanokai Samoncho Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro, Toshima-ku, Tokyo, JAPAN
Tel
03-6868-7022
jccr-info@jccr.jp
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
医療法人社団 信濃会 左門町クリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 22 | 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
29
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
| 2021 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052587
