UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of blood lactate acid as index of muscle fatigue recovery
Title of the study (Brief title)	Validity of blood lactate acid
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, an effective procedure for stretching and citric acid intake, which is used as a method of muscle fatigue restoration, will be studied with the blood lactate value as an index of effect determination.
Basic objectives2	Others
Basic objectives -Others	In this study, an effective procedure for stretching and citric acid intake, which is used as a method of muscle fatigue restoration, will be studied with the blood lactate value as an index of effect determination. As a result of this study, if the effective implementation contents of stretching and citric acid intake are clarified, there is a possibility that in the clinical practice of physical therapy, more appropriate support including not only exercise but also recovery of muscle fatigue by exercise is possible is there.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in blood lactate acid before and after intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Other
Interventions/Control_1	Presence / absence of stretching,
Interventions/Control_2	timing of ingestion of citric acid
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	1. Adult (both male and female are acceptable). It also covers Shinshu University and hospital officials, students, and those belonging to the medical department. 2. Person who got written consent based on his her free will after receiving sufficient explanation for participation in this research
Key exclusion criteria	1.Person who regularly ingests ascorbic acid, supplement containing L-cysteine. 2. Pregnant women. 3. Person who is administered a biguanite agent. 4. Persons undergoing confirmed diagnosis of lactic acidosis. 5. In addition, patients whose research managers judged inappropriate as subjects
Target sample size	40

Research contact person
Name of lead principal investigator	Hitomi Nishizawa
Organization	Shinshu University
Division name	School of Medicine Department of Health Sciences
Address	3-1-1 Asahi Matsumoto City, Nagano Prefecture
TEL	0263-37-2414
Email	hitnishi@shinshu-u.ac.jp

Public contact
Name of contact person	Hitomi Nishizawa
Organization	Shinshu University
Division name	School of Medicine Department of Health Sciences
Address	3-1-1 Asahi Matsumoto City, Nagano Prefecture
TEL	0263-37-2414
Homepage URL
Email	hitnishi@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Shinshu University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	nishiza-748
Org. issuing International ID_1	Shinshu University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 02 Month 04 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 02 Month 18 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040920