UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034873 |
|---|---|
| Receipt number | R000038320 |
| Scientific Title | The effect of low-carbohydrate diet on blood glucose levels on healthy individuals |
| Date of disclosure of the study information | 2018/11/15 |
| Last modified on | 2022/05/18 11:21:19 |
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Basic information
Public title
The effect of low-carbohydrate diet on blood glucose levels on healthy individuals
Acronym
The effect of low-carbohydrate diet on bolood glucose levels on healthy individuals
Scientific Title
The effect of low-carbohydrate diet on blood glucose levels on healthy individuals
Scientific Title:Acronym
The effect of low-carbohydrate diet on bolood glucose levels on healthy individuals
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effect of low-carbohydrate diet on blood glucose parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
postprandial glucose values
Key secondary outcomes
Area under the curve for glucose
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
High-carbohydrate meal
Participants wear the flash glucose monitoring (FGM) for 8 days. They consume test meals from the fourth to the seventh day, and consume high-carbohydrate diet on the fourth and the sixth day, and consume low-carbohydrate diet on the fifth day. The daily glucose parameters were compared during the 3 study period.
Interventions/Control_2
Low-carbohydrate meal
Participants wear the flash glucose monitoring (FGM) for 8 days. They consume test meals from the fourth to the seventh day, and consume high-carbohydrate diet on the fourth and the sixth day, and consume low-carbohydrate diet on the fifth day. The daily glucose parameters were compared during the 3 study period.
Interventions/Control_3
High-carbohydrate meal 2
Participants wear the flash glucose monitoring (FGM) for 8 days. They consume test meals from the fourth to the seventh day, and consume high-carbohydrate diet on the fourth and the sixth day, and consume low-carbohydrate diet on the fifth day. The daily glucose parameters were compared during the 3 study period.
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy volunteers
2.Individuals whose written informed consents have been obtained
3.Individuals who are judged appropriate for the study by the principal
Key exclusion criteria
1.Patients with type 1 and type 2 diabetes
2.Treatment with steroid
3.Women with possibility of pregnancy
4.Severe health problems not suitable for this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Food and Nutrition
Zip code
605-8501
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL
075-531-7128
imais@kyoto-wu.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Food and Nutrition
Zip code
605-8501
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL
075-531-7128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Kyoto Women's University
Department of Food and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Department of Food and Nutrition
Kyoto Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kajiyama Clinic, Kyoto
Name of secondary funder(s)
Kajiyama Clinic, Kyoto
IRB Contact (For public release)
Organization
Kyoto Women's University
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
Tel
075-531-7128
imais@kyoto-wu.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
京都女子大学(京都）、梶山内科クリニック(京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
DOI: 10.6133/apjcn.202112_30(4).0006
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34967188/
Number of participants that the trial has enrolled
22
Results
Twenty-two women wore flash glucose monitoring system and consumed test meals for 3 days from Day 4 to 6. Participants consumed identical HCD meals except LCD dinner on Day 5. The glucose parameters were all significantly lower than those of HCD dinner on Day 4 and 6. However, consuming LCD only once is enough to cause 24-h higher postprandial blood glucose concentration in subsequent consumption of HCD in healthy women.
Results date posted
| 2022 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Randomized controlled cross-over trial
Adverse events
Outcome measures
MBG, SD, incremental area under the curves (IAUC) for glucose of breakfast, lunch, and dinner
IGP
mean amplitude of glycemic excursion (MAGE)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 13 | Day |
Last modified on
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038320
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/05/18 | Imai S et al..pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/05/18 | Imai S et al..pdf |
| Research case data | |
|---|---|
| Registered date | File name |
