UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035727 |
|---|---|
| Receipt number | R000040698 |
| Scientific Title | Effects of yeast drink intake on GI value |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2021/02/16 19:03:24 |
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Basic information
Public title
Effects of yeast drink intake on GI value
Acronym
Effects of yeast drink intake on GI value
Scientific Title
Effects of yeast drink intake on GI value
Scientific Title:Acronym
Effects of yeast drink intake on GI value
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of yeast drink intake on GI value.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level and GI value
Key secondary outcomes
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
Eat 150g retort rice (cooked rice by Sato food koshihikari-100% natural made in Niigata) as a control. Take a diluted yeast drink (1/6 or 1/7 dilution from a 64ml concentrated yeast drink with water) as an experiment.
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 and Female
Key inclusion criteria
1.20 to 49 years old (at the time of submission of an informed consent document).
2. Healthy adults ("Healthy" is defined as those who currently have neither severe organ damage nor a particular disease, those who currently do not receive treatment associated with the above disorders, and those who currently do not receive any kind of drug treatment. The principal investigator judges whether or not a candidate meets this definition according to the self-report submitted when a clinical trial is commenced).
3. Males and females.
4. Body mass index (BMI) of 30 kg/m2 or lower.
5. Those who have not been diagnosed with impaired glucose tolerance over the past one year.
6. Those who can abstain from foods that affect intestinal bacteria, such as yeast-containing foods, yogurt, probiotic fermented foods, and foods for specified health use while participating in this clinical trial.
7. Those who do not change or those who are not planning to change their lifestyles while participating in this clinical trial.
8. Those who can provide their written informed consent.
Key exclusion criteria
1. Those who currently receive treatment with some types of drugs and Chinese herbal medicines (except for the drugs that are taken as needed).
2. Those with a past medical history of treatment for heart failure, heart attack, etc.
3. Those who have undergone gastrointestinal surgery (except for appendectomy).
4. Those with a past medical history of any of the following: hepatic or other major disorders (kidneys, endocrine, cardiovascular, gastrointestine, lungs, blood, and metabolism), or complications of the disorders listed above. (Those who are in treatment for atrial fibrillation, arrhythmia, hepatic or renal impairment, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases).
5. D criteria for comprehensive medical examination (D stands for "requiring medical treatment"). Except for a value within the range of two standard errors judged by a physician.
6. Those who currently take health foods (including food products to maintain or restore health, supplements, etc.).
7. Those with a past and current medical history of drug or food allergy.
8. Those who are currently participating in another clinical trial or those who participated in another clinical trial within a month prior to submission of an informed consent document.
9. Those who are currently pregnant or breastfeeding and those who desire a pregnancy.
10. In the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Tada |
Organization
The First Yeast Co. Ltd.
Division name
Senior Managing Director
Zip code
410-2113
Address
261-1, Naka, Izunokuni, Shizuoka
TEL
055-940-3050
k-tada@dream.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yuzawa |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
The First Yeast 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
n-yuzawa@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
| 2019 | Year | 02 | Month | 01 | 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
| 2019 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 31 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040698
| Research Plan | |
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| Registered date | File name |
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