UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048929 |
|---|---|
| Receipt number | R000055672 |
| Scientific Title | Effects of Concentrated Liquid Diet Containing Palatinose and Guar Gum Degradants on Blood Glucose Trends in Patients with Mild Impaired Glucose Tolerance |
| Date of disclosure of the study information | 2022/09/16 |
| Last modified on | 2023/06/05 09:58:13 |
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Basic information
Public title
Effects of Concentrated Liquid Diet Containing Palatinose and Guar Gum Degradants on Blood Glucose Trends in Patients with Mild Impaired Glucose Tolerance
Acronym
Effects of Concentrated Liquid Diet ``Recovery K5'' on Blood Glucose Trends in Patients with Mild Impaired Glucose Tolerance
Scientific Title
Effects of Concentrated Liquid Diet Containing Palatinose and Guar Gum Degradants on Blood Glucose Trends in Patients with Mild Impaired Glucose Tolerance
Scientific Title:Acronym
Effects of Concentrated Liquid Diet ``Recovery K5'' on Blood Glucose Trends in Patients with Mild Impaired Glucose Tolerance
Region
| Japan |
Condition
Condition
mild diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The blood sugar trend when ingesting the liquid concentrated liquid diet "Recovery K5 (manufactured by Nutri)" is compared with that when ingesting the medical enteral nutritional supplement (liquid concentrated liquid diet) "Ensure Liquid (manufactured by Abbott)". Efficacy will be verified by comparing with blood sugar trends.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood sugar trend
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Recovery K5 (Nutri)/Ensure Liquid (Abbott)
Interventions/Control_2
Ensure Liquid (Abbott)/Recovery K5 (Nutri)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Outpatients at Kato Internal Medicine Clinic, (2) HbA1c in the range of 5.8% to 7.0% as a guide, (3) Patients who have not taken hypoglycemic drugs for 4 weeks or more before the start of this study, (4) Patients who have consented to cooperate with this study and are 20 years of age or older.
Key exclusion criteria
Severely diabetic
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mitsutoshi |
| Middle name | |
| Last name | Kato |
Organization
Kato Clinic of Internal Medicine
Division name
Clinic Director
Zip code
125-0054
Address
3-11-14 Station Heights Takasago 201,Takasago, Katsushika-ku,Tokyo
TEL
03-5668-2161
katom@gol.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kashimura |
Organization
Mitsui Sugar Co.,Ltd
Division name
Business Development Division
Zip code
103-8423
Address
36-2, Nihonbashi-Hakozakicho Chuo-ku, Tokyo
TEL
0336399353
Homepage URL
jun.kashimura@dmms-hd.com
Sponsor or person
Institute
Kato Clinic of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsui Sugar Co.,ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kato Clinic of Internal Medicine
Address
3-11-14 Station Heights Takasago 201,Takasago, Katsushika-ku,Tokyo
Tel
0356682161
katom@gol.com
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 | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
