UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043531 |
|---|---|
| Receipt number | R000049711 |
| Scientific Title | Investigation on Effect of Ingestion of Yeast on Degradation of Glucose and Postprandial Blood Glucose Level - A Randomized, Double-blinded, Crossover Comparative Study - |
| Date of disclosure of the study information | 2021/03/26 |
| Last modified on | 2021/10/07 10:25:52 |
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Basic information
Public title
Investigation on Effect of Ingestion of Yeast on Degradation of Glucose and Postprandial Blood Glucose Level - A Randomized, Double-blinded, Crossover Comparative Study -
Acronym
Investigation on Effect of Ingestion of Yeast on Degradation of Glucose and Postprandial Blood Glucose Level
Scientific Title
Investigation on Effect of Ingestion of Yeast on Degradation of Glucose and Postprandial Blood Glucose Level - A Randomized, Double-blinded, Crossover Comparative Study -
Scientific Title:Acronym
Investigation on Effect of Ingestion of Yeast on Degradation of Glucose and Postprandial Blood Glucose Level
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of continuous ingestion of the study food on breath carbon dioxide and postprandial blood glucose level
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose area under the curve (AUC)
Key secondary outcomes
Change in insulin level over time, Change in blood glucose level over time, Insulin area under the curve (AUC), Breath carbon dioxide content, Blood ethanol concentration, Body fat percentage, Abdominal circumference
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Study food will be ingested twice daily, for 2 weeks.
Interventions/Control_2
Placebo will be ingested twice daily, for 2 weeks.
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.Age between 20 and 65 years at the time of informed consent
2.Japanese male or female
3.Those who have a fasting blood glucose level of less than 126 mg/dL at the time of screening.
4.Those who have an HbA1c value of less than 6.5% at the time of screening
5.Those who is able to have blood collected multiple times a day
6.BMI of less than 30 kg/m2
7.Those who are able to input electronic diary with smartphone / PC
8.Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent
Key exclusion criteria
1.Those who has been currently visiting a hospital or treated with any drug or herbal remedy (however, dosing as needed is allowed) for any disease
2.On diet / exercise therapy under the guidance of a doctor
3.Have a current or history of serious illness
4.Those who regularly uses any quasi-drug, food for specified health use, health food or supplement that is considered to affect glucose degradation and blood glucose level (however, the person will be eligible if he/she can stop using it during the study period after provision of the informed consent)
5.Current or history of drug allergies or food allergies
6.Those who have a current or a past medical history of drug or alcohol dependence
7.Those who work in shifts, or night shifts
8.Alcohol consumption of >60g equivalent
9.Those who have excessive smoking habits (21 or more cigarettes / day)
10.Planning to significantly change their lifestyle (diet, sleep, exercise, etc.) during the trial
11.Pregnant or lactating, or willing to be pregnant during the trial
12.Participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate
13.Judged by the investigator to be unsuitable for participating in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Iwamoto |
Organization
Nikkenkyo Service Co., Ltd.
Division name
General Manager for Research & Development
Zip code
369-0134
Address
12 Sanchomen Konosu-shi Saitama Japan
TEL
048-580-6108
yasushi.iwamoto@nkks.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
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
y-hira@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
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
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
| 2021 | Year | 03 | Month | 26 | 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
30
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
| 2021 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049711
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| Registered date | File name |
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