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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046074
Receipt No. 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 2021/11/17

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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
Email 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
Email takaoka-ryosuke@3hcts.co.jp

Sponsor
Institute Medical corporation
Shinanokai Samoncho Clinic
Institute
Department

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
Email 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
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 Preinitiation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 15 Day
Last modified on
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052587

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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