UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057403 |
|---|---|
| Receipt number | R000065218 |
| Scientific Title | Investigation of the Effects of Low-Carbohydrate Preference Foods on Blood Glucose Control |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/03/18 00:53:31 |
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Basic information
Public title
Study on the Effects of Low-Carbohydrate Foods on Blood Glucose Control
Acronym
Low-Carbohydrate Foods and Blood Glucose Control
Scientific Title
Investigation of the Effects of Low-Carbohydrate Preference Foods on Blood Glucose Control
Scientific Title:Acronym
Low-Carbohydrate Preference Foods and Blood Glucose Control
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effectiveness of low-carbohydrate snacks by examining the impact on blood glucose control when patients with type 2 diabetes consume regular ice cream and low-carbohydrate ice cream.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in blood glucose increase (Max value - 0 min value) between regular ice cream and low-carbohydrate ice cream consumption.
Key secondary outcomes
The differences in the following parameters between regular ice cream and low-carbohydrate ice cream consumption:
AUC 0 to120 min Difference in AUC from 0 to 120 minutes measured by blood sampling and FreeStyle Libre 2.
AUC 0 to 180 min Difference in AUC from 0 to 180 minutes measured by FreeStyle Libre 2.
Insulin peak value Difference in maximum insulin levels.
Blood glucose increase at specific time points Differences in blood glucose levels at 15, 30, 60, and 120 minutes measured by blood sampling.
Triglyceride response Differences in maximum triglyceride levels and triglyceride increase.
Incretin response Difference in the maximum levels of incretins, including GLP-1.
Sensory evaluation Differences in subjective ratings of each ice cream based on a questionnaire.
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low-carbohydrate ice cream
Interventions/Control_2
placebo
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Outpatients with type 2 diabetes
2. Patients who can provide written informed consent to participate in the study of their own free will
3. Patients aged 18 to 89 years at the time of consent acquisition
Key exclusion criteria
Women who are pregnant or may be pregnant
Patients who have had changes in diabetes medication within the past six months
Patients taking a glucosidase inhibitors
Patients with a history of vasovagal reflex due to blood sampling
Individuals deemed inappropriate by their primary physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Fukui |
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
602-8566
Address
Kajiicho465, Kawaramachidori hirokoji, Kamigyoku, Kyoto City
TEL
075-251-5505
michiaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Shinta |
| Middle name | |
| Last name | Yamamoto |
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
602-8566
Address
Kajiicho465, Kawaramachidori hirokoji, Kamigyoku, Kyoto City
TEL
075-251-5505
Homepage URL
todayweb@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Address
Kajiicho465, Kawaramachidori hirokoji, Kamigyoku, Kyoto City
Tel
075-251-5111
kikaku01@koto.kpu-m.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
| 2025 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065218
