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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043531
Receipt No. 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

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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
Email 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
Email y-hira@imeqrd.co.jp

Sponsor
Institute IMEQRD Co., Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049711

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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