UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039372
Receipt number 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 14:49:28

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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 or person

Institute

imeQ RD inc.

Institute

Department

Personal name



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

Value
https://center6.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