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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035391
Receipt No. R000040325
Scientific Title Effects of a single ingestion of trehalose on exercise performance
Date of disclosure of the study information 2018/12/28
Last modified on 2018/12/28

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Basic information
Public title Effects of a single ingestion of trehalose on exercise performance
Acronym Effects of a single ingestion of trehalose on exercise performance
Scientific Title Effects of a single ingestion of trehalose on exercise performance
Scientific Title:Acronym 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
1st name
Middle name
Last name Tsuyoshi Wadazumi
Organization Kansai University
Division name Faculty of Health and Well-being
Zip code
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
1st name
Middle name
Last name Tsuyoshi Wadazumi
Organization Kansai University
Division name Faculty of Health and Well-being
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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

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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