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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035727
Receipt No. R000040698
Scientific Title Effects of yeast drink intake on GI value
Date of disclosure of the study information 2019/02/01
Last modified on 2019/04/03

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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
Middle name
Last name Kazumasa Tada
Organization The First Yeast Co. Ltd.
Division name Senior Managing Director
Zip code
Address 261-1, Naka, Izunokuni, Shizuoka
TEL 055-940-3050
Email k-tada@dream.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6225-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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
Address
Tel
Email

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
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040698

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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