UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053387 |
|---|---|
| Receipt number | R000060931 |
| Scientific Title | A randomized, single-blind, placebo-controlled, crossover study on the suppressive effects of viscosity-adjusted enteral formula on blood glucose level |
| Date of disclosure of the study information | 2024/01/25 |
| Last modified on | 2024/01/18 14:08:14 |
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Basic information
Public title
Suppressive effects of a test food on blood glucose level
Acronym
Suppressive effects of a test food on blood glucose level
Scientific Title
A randomized, single-blind, placebo-controlled, crossover study on the suppressive effects of viscosity-adjusted enteral formula on blood glucose level
Scientific Title:Acronym
Suppressive effects of a test food on blood glucose level
Region
| Japan |
Condition
Condition
Patients receiving enteral tube feeding
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of viscosity-adjusted enteral formula on blood glucose level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of postprandial blood glucose
Key secondary outcomes
Blood glucose, insulin level, blood amino acids, GLP-1 level, and GIP level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Single ingestion of placebo food, washout period for 2 weeks, single ingestion of test food.
Interventions/Control_2
Single ingestion of test food, washout period for 2 weeks, single ingestion of placebo food.
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects aged 50 or more and less than 65.
Key exclusion criteria
1)Subjects who meet both of the following criteria in the preliminary survey.
i)Fasting blood glucose level is 126 mg/dL or more.
ii)HbA1c value is 6.5 % or more.
2)Subjects who have been diagnosed with diabetes.
3)Subjects taking medications that may affect blood glucose levels.
4)Subjects who are under medical treatment of diseases in liver, kidneys, heart, lungs, digestive system, blood, endocrine and metabolic systems, or who have serious medical history of those diseases.
5)Subjects who exhibit allergic symptoms due to intake of milk or soybean-derived ingredients.
6)Subjects who donated/collected blood components or 200 mL or more of blood in the past 1 month, or who donated/collected 400 mL or more of blood on the past 4 months.
7)Subjects who plan to participate in other clinical trials during the trial period.
8)Others who are judged by the investigator to be inappropriate as participants in this test.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Oki |
Organization
Seishukai Clinic
Division name
urology
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo, Japan
TEL
03-5827-0930
t-takahama@seishukai.or.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sonoki |
Organization
Morinaga Milk Industry Co., LTD.
Division name
Health Care & Nutritional Science Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-city, Kanagawa Pref. Japan
TEL
046-252-3057
Homepage URL
h-sonoki@morinagamilk.co.jp
Sponsor or person
Institute
Seishukai Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Japan Conference of Clinical Research
Address
1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@jccr.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
医療法人社団 成守会 成守会クリニック/Seishukai Clinic
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 25 | 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
| 2023 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060931
| 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 |
