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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039372
Receipt No. 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 2020/07/21

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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
Email a.okamoto@sunnyhealth.co.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL 03-6205-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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 03-6205-6222
Email suda-clinic_irb@imeq.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
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044895

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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