UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046921 |
|---|---|
| Receipt number | R000053489 |
| Scientific Title | Validation of inhibiting effects by taking a single dose of test food, on a rise in postprandial blood-sugar level. |
| Date of disclosure of the study information | 2023/02/18 |
| Last modified on | 2023/02/07 12:21:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation of inhibiting effects by taking a single dose of test food, on a rise in postprandial blood-sugar level.
Acronym
Validation of inhibiting effects by taking a single dose of test food, on a rise in postprandial blood-sugar level.
Scientific Title
Validation of inhibiting effects by taking a single dose of test food, on a rise in postprandial blood-sugar level.
Scientific Title:Acronym
Validation of inhibiting effects by taking a single dose of test food, on a rise in postprandial blood-sugar level.
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify some kind of inhibiting effect on a rise in after-meal blood-sugar level, by taking a single dose of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the blood glucose concentration-time curve
Key secondary outcomes
1. Postprandial blood-sugar level
2. Blood-sugar level (Cmax)
3. Blood-sugar level (Tmax)
4. Insulin level
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
Consumption of the test food (1 package) with water (150 mL) to the subjects.
Interventions/Control_2
Consumption of the placebo food (1 package) with water (150 mL) to the subjects.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 20 to 64 at informed consent.
(2) Subjects having less than 126 mg/dL of blood-sugar level on an empty stomach, and less than 200 mg/dL of the level at the time point of 2 hrs. after a carbohydrate tolerance.
(3) Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who take steadily in the health-specific/functional/supplementary/health foods which might affect this trial, and have any difficulty in giving up taking them during this trial.
(2) Subjects who take steadily in the medicines and herbal ones which might affect this trial, and have any difficulty in giving up taking them during this trial.
(3) Subjects having not less than 30.0 kg/m2 of BMI.
(4) Subjects with excessive alcohol intake.
(5) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(6) Pregnant, possibly pregnant, and lactating women.
(7) Subjects having drug and/or food allergy (especially in milk).
(8) Subjects who are under other clinical trials with some kind of medicine/food, or participated in those within the last four weeks before this trial, or are planning to join those after the consent.
(9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial.
(10) Males who donated their whole blood (400 mL) within the last three months to this trial.
(11) Females who donated their whole blood (400 mL) within the last four months to this trial.
(12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Iwamoto |
Organization
Nikkenkyo Service Co., Ltd.
Division name
Director in charge of R & D
Zip code
369-0134
Address
12 Sanchomen, Konosu-shi, Saitama 369-0134, Japan
TEL
048-580-6108
yasushi.iwamoto@nkks.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nikkenkyo Service 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2023 | Year | 02 | Month | 18 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2022 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053489
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
