UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052587