UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029584
Receipt No. R000033795
Scientific Title Effect of pre-exercise carbohydrate ingestion on high intensity intermittent exercise performance
Date of disclosure of the study information 2017/10/16
Last modified on 2020/07/28 (Ver. 6)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title Effect of pre-exercise carbohydrate ingestion on high intensity intermittent exercise performance
Acronym Pre-exercise carbohydrate ingestion and exercise performance
Scientific Title Effect of pre-exercise carbohydrate ingestion on high intensity intermittent exercise performance
Scientific Title:Acronym Pre-exercise carbohydrate ingestion and exercise performance
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the influence of pre-exercise ingestion of different carbohydrate on high intensity intermittent exercise performance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cyclic ergometer
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Single pre-exercise ingestion of carbohydrate
Interventions/Control_2 Single pre-exercise ingestion of glucose
Interventions/Control_3 Single pre-exercise ingestion of water
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
18 years-old <=
Age-upper limit
25 years-old >=
Gender Male
Key inclusion criteria Male healthy distance runner
Key exclusion criteria 1) Subjects receiving treatment (medicine prescription by a doctor)
2) Subjects suffering from serious cardiovascular disorder, liver function disorder, renal dysfunction, respiratory disorder, endocrine disorder, metabolic disorder, or those having history of them
3) Subjects with history of chest pain or fainting.
4) Subjects who are likely to cause allergies related to the test supplement
5) Subjects who donated 200 mL within 1 month prior to the start of the study, or 400 mL (blood donation etc.) within 3 months
6) Smokers
7) Subjects who are judged as unsuitable for this study by physician.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code
Address 1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL +81-476-98-1001
Email yssuzuki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code
Address 1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL +81-476-98-1001
Homepage URL
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Health and Sports Science
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 順天堂大学さくらキャンパス（千葉県）

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 16 Day

Related information
URL releasing protocol https://journals.sagepub.com/doi/10.1177/1934578X20933727
Publication of results Published

Result
URL related to results and publications https://journals.sagepub.com/doi/10.1177/1934578X20933727
Number of participants that the trial has enrolled 10
Results 
Described in the article
Results date posted
2020 Year 07 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 07 Month 28 Day
Baseline Characteristics 
Shown as Table 3 in the published article
Participant flow 
Shown as Figure 2 in the published article
Adverse events 
none
Outcome measures 
The mean power and peak pedaling speed
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 09 Month 05 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2017 Year 10 Month 18 Day
Last follow-up date
2017 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 16 Day
Last modified on
2020 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033795