UMIN-CTR Clinical Trial

Basic information
Public title	Effects of daily carbohydrate intake on glucose metabolism and blood glucose variability
Acronym	Daily carbohydrate intake, glucose metabolism, and blood glucose variability
Scientific Title	Effects of daily carbohydrate intake on glucose metabolism and blood glucose variability
Scientific Title:Acronym	Daily carbohydrate intake, glucose metabolism, and blood glucose variability
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of daily carbohydrate intake on carbohydrate metabolism and blood glucose variability
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose variability
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single day high-carbohydrate diet (carbohydrate 8.1 g/kg/d)
Interventions/Control_2
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	BMI ranged from 18.5 to 25.0
Key exclusion criteria	1) Who are prohibited exercise by the medical doctor 2) Who have or have history of mental disorder 3) Who taking hormonal agents 4) Who have history of digestive surgery 5) Who have medical history in kidney 6) Constant use of medicine 7) Who acquire acute infection 8) Who drink a lot of alcohol or smoke 9) Whose eating habits are extremely irregular 10) Who participate or are willing to participate clinical trials of other food products, drugs, or beauty products. 11) Who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shiose Middle name Last name Keisuke
Organization	Fukuoka university
Division name	Faculty of Sports and Health Science
Zip code	814-0180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	092-871-6631
Email	kei_shiose@yahoo.co.jp

Public contact
Name of contact person	1st name Shiose Middle name Last name Keisuke
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Zip code	814-0180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL	092-871-6631
Homepage URL
Email	kei_shiose@yahoo.co.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Fukuoka University
Address	8-19-1 Nanakuma, Jonan-ku,Fukuoka, Japan
Tel	092-871-6631
Email	suisin@adm.fukuoka-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 23 Day

Related information
URL releasing protocol	https://www.jstage.jst.go.jp/article/jpfsm/8/6/8_310/_pdf/-char/ja
Publication of results	Partially published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/jpfsm/8/6/8_310/_pdf/-char/ja
Number of participants that the trial has enrolled	20
Results	Daily carbohydrate intakes were associated with blood glucose variability in response to carbohydrate overfeeding
Results date posted	2022 Year 05 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy male Mean age, 21.4 yr Mean BMI, 21.2 kg/m2
Participant flow	Subjects were divided into two groups based on their daily carbohydrate intake
Adverse events	None
Outcome measures	Blood glucose variability Carbohydrate oxidation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 08 Day
Date of IRB	2018 Year 03 Month 08 Day
Anticipated trial start date	2018 Year 03 Month 09 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 22 Day
Last modified on	2022 Year 05 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054351