UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054038 |
|---|---|
| Receipt number | R000061693 |
| Scientific Title | Effects of continuous consumption of the test food on postprandial blood glucose level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/04/02 |
| Last modified on | 2024/12/23 09:14:19 |
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Basic information
Public title
Effects of continuous consumption of the test food on postprandial blood glucose level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of continuous consumption of the test food on postprandial blood glucose level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of continuous consumption of the test food on postprandial blood glucose level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of continuous consumption of the test food on postprandial blood glucose level in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of continuous consumption of the test food on postprandial blood glucose level in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of the incremental area under the curve (IAUC) of the blood glucose level at 12 weeks after consumption (12w) [Active food 2 vs. Placebo food]
Key secondary outcomes
1. The measured values of the IAUC of blood glucose level at 12w [Active food 1 vs. Placebo food, Active food 3 vs. Placebo food]
2. The changes from screening (before consumption; Scr) of the IAUC of blood glucose level at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food]
3. The measured values and changes from Scr of the maximum blood concentration (Cmax) of blood glucose level at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food]
4. The measured values and changes from Scr of the fasting blood glucose level (before consumption of the carbohydrate load) and blood glucose level 30, 60, 90, and 120 minutes after consumption of the carbohydrate load at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food]
5. The measured values and changes from Scr of insulin, body fat percentage, fat mass, and muscle mass at 12w [Active food 2 vs. Placebo food, Active food 1 vs. Placebo food, Active food 3 vs. Placebo food]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Active food 1
Interventions/Control_2
Duration: 12 weeks
Test food: Active food 2
Interventions/Control_3
Duration: 12 weeks
Test food: Active food 3
Interventions/Control_4
Duration: 12 weeks
Test food: Placebo food
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals whose Cmax of blood glucose level after consumption of the carbohydrate load is 140-199 mg/dL at Scr
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day
5. Individuals who take dairy products such as milk and cheese at least four times a week
6. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
7. Individuals who are taking or using medications (including herbal medicines) and supplements
8. Individuals who are allergic to medications and/or the test food related products (particularly gelatin)
9. Individuals who are pregnant, lactating, or planning to become pregnant during this study
10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
11. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
J-OIL MILLS, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Chiba University
Name of secondary funder(s)
Raffinee International Inc.
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 02 | 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
100
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
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 20 | 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 | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061693
