UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047826 |
|---|---|
| Receipt number | R000054351 |
| Scientific Title | Effects of daily carbohydrate intake on glucose metabolism and blood glucose variability |
| Date of disclosure of the study information | 2022/05/23 |
| Last modified on | 2022/05/22 10:56:00 |
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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
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
kei_shiose@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054351
