UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039372 |
|---|---|
| Receipt number | R000044895 |
| Scientific Title | Validation study of time-dependent change of blood glucose level after taking yeast-containing foods. |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2024/05/21 14:31:37 |
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Basic information
Public title
Validation study of time-dependent change of blood glucose level after taking yeast-containing foods.
Acronym
Validation study of time-dependent change of blood glucose level after taking yeast-containing foods.
Scientific Title
Validation study of time-dependent change of blood glucose level after taking yeast-containing foods.
Scientific Title:Acronym
Validation study of time-dependent change of blood glucose level after taking yeast-containing foods.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to validate time-dependent change of blood glucose level in men (aged 20-49) with a BMI (body mass index) of less than 25 kg/m2 who ate a test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-dependent changes of blood glucose levels.
Key secondary outcomes
Time-dependent changes of blood insulin levels.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take specified foods only or take both one packet test food (4g) and specified food with a glass of water or hot water.
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1. 20 to 49 years old (at the time of submission of an informed consent document).
2. Men.
3. Those who have a BMI of less than 25 kg/m2 at the time of screening.
4. Those who have a fasting blood glucose level of less than 126 mg/dL at the time of screening.
5. Those who have a 120-min casual blood glucose level of less than 200 mg/dL at the time of screening.
6. Those who have an HbA1c value of less than 6.5% at the time of screening.
7. Smartphone or PC users (who can input their own data into the electronic diary).
8. Those who can receive sufficient explanation of the purpose and content of this study, who have ability to agree with the above explanation, who voluntarily participate in this study after coming to a better understanding, and who can give written informed consent.
9. Those who do not change or do not intend to change daily life habits during the study period.
Key exclusion criteria
1. Those who are currently receiving some types of drug (except for the drugs that are taken as needed).
2. Those who are receiving nutrition therapy or physical therapy under a doctor's supervision.
3. Those who have or had a severe disease of the liver, kidneys, endocrine, heart ,gastrointestinal tract, respiratory system, blood, and metabolism.
4. Those who underwent gastrointestinal surgery.
5. Those who are currently taking the following products which affect glucose blood level: pharmaceutical products, health foods, or supplements.
6. Those who have a past and current medical history of drug or food allergy.
7. Those who may have allergic reactions to test food.
8. Those who work night shifts.
9. Smokers.
10. Heavy drinkers.
11. Those who are currently participating in another clinical trial or who had participated in another clinical trial conducted within a month prior to the submission of an informed consent document.
12. Those who experienced a feeling of being unwell or deterioration of health condition when they had blood drawn.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Okamoto |
Organization
Sunny Health Co.,Ltd
Division name
Product Development Department
Zip code
104-0028
Address
2-1-6,Yaesu Chuo-ku Tokyo
TEL
03-6701-3021
a.okamoto@sunnyhealth.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sunny Health Co.,Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2020 | Year | 02 | Month | 03 | 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
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044895
