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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030159
Receipt No. R000033527
Scientific Title Sports nutrition study of carbohydrate
Date of disclosure of the study information 2017/11/28
Last modified on 2018/11/29

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Basic information
Public title Sports nutrition study of carbohydrate
Acronym Sports nutrition study of carbohydrate
Scientific Title Sports nutrition study of carbohydrate
Scientific Title:Acronym Sports nutrition study of carbohydrate
Region
Japan

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

Objectives
Narrative objectives1 Investigation of carbohydrate intake on fat metabolism during endurance exercise
Basic objectives2 Others
Basic objectives -Others Investigation of carbohydrate intake on exercise performance during endurance exercise
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes respiratory quotient
Key secondary outcomes time trial
blood glucose
plasma insulin
blood lactate
plasma free fatty acid
heart rate
electromyogram
ratings of perceived exertion
visual analog scale

Base
Study type Interventional

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

Intervention
No. of arms 6
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Glucose intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Slowly Digestible Highly Branched Cyclic Dextrin (Ezaki Glico Co., Ltd., Carbohydrate A) intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Dextrin with dextrose equivalent (DE) from 16 to 25 (Carbohydrate B) intake: 10 g/100 mL, 6 times, 4 hours
Interventions/Control_2 Glucose intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Carbohydrate B intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Carbohydrate A intake: 10 g/100 mL, 6 times, 4 hours
Interventions/Control_3 Carbohydrate A intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Glucose intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Carbohydrate B intake: 10 g/100 mL, 6 times, 4 hours
Interventions/Control_4 Carbohydrate A intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Carbohydrate B intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Glucose intake: 10 g/100 mL, 6 times, 4 hours
Interventions/Control_5 Carbohydrate B intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Glucose intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Carbohydrate A intake: 10 g/100 mL, 6 times, 4 hours
Interventions/Control_6 Carbohydrate B intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Carbohydrate A intake: 10 g/100 mL, 6 times, 4 hours
Wash out: more than 3 dyas
Glucose intake: 10 g/100 mL, 6 times, 4 hours
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria Those with athletic ability to complete a 3 hour bicycle exercise program.
Key exclusion criteria 1) Those who routinely use medicine, supplements, FOSHU, and/or health food which affect to result of the study.
2) Those who are contracting diabetes.
3) Those who planning to become pregnant or lactating during the examination period.
4) Heavy user of alcohol or excessive smokers.
5) Those who were judged as inappropriate for subjects by the principal investigator.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Ishihara
Organization Ryukoku University
Division name Faculty of Agriculture
Zip code
Address 1-5, Yokotani, Seta Oe-cho, Otsu, Shiga, Japan
TEL +81-77-599-5611
Email kengo@agr.ryukoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Terada
Organization Ezaki Glico Co., Ltd.
Division name Institute of Health Sciences
Zip code
Address 4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL +81-6-6477-8425
Homepage URL
Email terada-yoshinobu@glico.co.jp

Sponsor
Institute Ryukoku University
Institute
Department

Funding Source
Organization Ezaki Glico 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
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 龍谷大学農学部

Other administrative information
Date of disclosure of the study information
2017 Year 11 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
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 29 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
2017 Year 11 Month 28 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033527

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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