UMIN-CTR Clinical Trial

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

Healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Ryukoku University

Institute

Department

Personal name

Organization

Ezaki Glico Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

龍谷大学農学部

Date of disclosure of the study information

2017

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

11

Month

28

Day

Last modified on

2018

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033527