UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sports nutrition study of carbohydrate
Title of the study (Brief title)	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	Kengo Ishihara
Organization	Ryukoku University
Division name	Faculty of Agriculture
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	Yoshinobu Terada
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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