UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a single ingestion of trehalose on exercise performance
Title of the study (Brief title)	Effects of a single ingestion of trehalose on exercise performance
Region	Japan

Condition
Condition	Healthy college students
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate the effects of a single ingestion of trehalose on 1) exercise performance (the Wingate test) during the later stages of prolonged exercise and 2) energy metabolism during low-intensity (40% VO2peak) constant-load exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	We compared performance in the Wingate test after a single ingestion of glucose and trehalose solutions in 25 healthy male college students.
Key secondary outcomes	We compared the effects of a single ingestion of glucose and trehalose solutions on energy metabolism during 1-hour exercise at 40% VO2peak in 34 healthy college students (24 males and 10 females).

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Glucose - Trehalose The subjects performed the examination of the same protocol a total of 3 times by randomly changing the type of the test drink to be ingested. The test drink ingested at the end of the first set was water (trial W), or an 8% glucose (trial G) or trehalose (trial T) solution. The subjects ingested 500 mL of the test drink within 5 minutes after the end of the first set.
Interventions/Control_2	Trehalose - Glucose The subjects performed the examination of the same protocol a total of 3 times by randomly changing the type of the test drink to be ingested. The test drink ingested at the end of the first set was water (trial W), or an 8% glucose (trial G) or trehalose (trial T) solution. The subjects ingested 500 mL of the test drink within 5 minutes after the end of the first set.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy college students
Key exclusion criteria	Not healthy college students
Target sample size	50

Research contact person
Name of lead principal investigator	Tsuyoshi Wadazumi
Organization	Kansai University
Division name	Faculty of Health and Well-being
Address	1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka
TEL	072-229-5022
Email	wadazumi@kansai-u.ac.jp

Public contact
Name of contact person	Tsuyoshi Wadazumi
Organization	Kansai University
Division name	Faculty of Health and Well-being
Address	1-11-1 Kaorigaoka-cho, Sakai-ku, Sakai-shi, Osaka
TEL	072-229-5022
Homepage URL
Email	wadazumi@kansai-u.ac.jp

Sponsor
Institute	Kansai University, Faculty of Health and Well-being
Institute
Department

Funding Source
Organization	Kansai University, Faculty of Health and Well-being
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hayashibara Co., Ltd.
Name of secondary funｄer(s)

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	2018 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 10 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	2018 Year 12 Month 28 Day
Last modified on	2018 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040325