UMIN-CTR Clinical Trial

Basic information
Public title	Effect of trehalose ingestion during prolonged exercise on subsequent maximal exercise performance
Acronym	Effect of trehalose ingestion during prolonged exercise on subsequent maximal exercise performance
Scientific Title	Single ingestion of trehalose enhances a prolonged exercise performance by effective use of glucose and lipid in healthy men
Scientific Title:Acronym	Single ingestion of trehalose enhances a prolonged exercise performance by effective use of glucose and lipid in healthy men
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investigate a mechanism of single ingestion of trehalose over the prolonged exercise performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood glucose
Key secondary outcomes	insulin, adrenaline

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Each participant single ingested 500ml of one of the three solutions during exercise. water (control) 8% glucose 8% trehalose
Interventions/Control_2	After fasting for 12 hr, using a bicycle ergometer, they first exercised with a constant load for 60 min (intensity: 40% VO2 peak). They then performed a constant load exercise for 30 min (intensity: 40% VO2 peak) between four sets of the 30-s Wingate test with a 4-min recovery period between each set.
Interventions/Control_3	Each participant ingested different solutions and performed the same exercise protocol three times at intervals of one week or more.
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	23 years-old >=
Gender	Male
Key inclusion criteria	healthy male college students
Key exclusion criteria	students not in good health
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Naomi Middle name Last name HAMADA
Organization	Higashiosaka Junior College
Division name	Department of Applied Food Science
Zip code	577-8567
Address	3-1-1, Nishidutsumigakuen-cho, Higashiosaka, Osaka 577-8567 Japan
TEL	06-6782-2824
Email	hamada-n@higashiosaka.ac.jp

Public contact
Name of contact person	1st name Naomi Middle name Last name HAMADA
Organization	Kansai University
Division name	Department of Health and Well-being Faculty of Health and Well-being
Zip code	590-8815
Address	1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
TEL	072-229-5022
Homepage URL
Email	hamada-n@higashiosaka.ac.jp

Sponsor
Institute	Kansai University
Institute
Department

Funding Source
Organization	HAYASHIBARA 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	Kansai University
Address	1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka 590-8515, JAPAN
Tel	072-229-5022
Email	hamada-n@higashiosaka.ac.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	関西大学（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 15 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	12
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	2018 Year 07 Month 01 Day
Date of IRB	2019 Year 03 Month 11 Day
Anticipated trial start date	2019 Year 03 Month 11 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 14 Day
Last modified on	2021 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048795