UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043321 |
|---|---|
| Receipt number | R000049458 |
| Scientific Title | A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level: Randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2022/06/30 13:45:24 |
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Basic information
Public title
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level
Acronym
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level
Scientific Title
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level: Randomized double-blind placebo-controlled trial
Scientific Title:Acronym
A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of test food intake on the suppression of the elevation of postprandial blood glucose after meal.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Blood glucose
*Measure at before ingestion and 15, 30, 45, 60, 90, and 120 minutes after ingestion.
- Area Under the Curve
Key secondary outcomes
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
1)Test food + rice 200 g, single ingestion
2)Wash out for 1 week
3)Placebo food + rice 200 g, single ingestion
Interventions/Control_2
1)Placebo food + rice 200 g, single ingestion
2)Wash out for 1 week
3)Test food + rice 200 g, single ingestion
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) Japanese male and female aged 20-64 years old at the time of the informed consent
2) Subjects whose fasting blood glucose level is less than 126 mg/dL or two-hour blood glucose level after 75 g glucose loading is less than 200 mg/dL at the screening test.
3) Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria
1)Subject who is considered as a diabetes by a doctor.
2)Subject who is taking medication or under medical treatment.
3)Subject who is under exercise therapy or dietetic therapy.
4)Subject who has an allergy for test food.
5)Subject who has or had a history of either medicine or alcohol dependence syndrome.
6)Subject who has or had a history of mental illness(depression) or sleep disturbance.
7)Subject who is on a night-shift or is a shift worker.
8)Subject whose lifestyle is extremely irregular.
9)Subject who has an unbalanced diet.
10)Subject who is current disease or history of brain disorder, cancer, immunity disorder, diabetes, liver disease(hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases.
11)Subject who is use health foods, supplements, and medicines that may affect diabetes.
12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
13)Subject who has blood drawn 200 mL within the past 1 months or 400 mL within the past 3 months from the day of the consent acquisition.
14)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
15)Subject who can't keep the daily records.
16)Subject who is judged as an inappropriate candidate according to the screening data.
17)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamatsu |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development
Zip code
615-8245
Address
1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan
TEL
075-748-9829
a-yamatsu@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
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
the ethics committees of Yoga Allergy Clinic
Address
4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
Tel
03-5491-4478
jim@medipharma.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
FH19-001
Org. issuing International ID_1
HUMA R&D CORP
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
とうきょうスカイツリー駅前内科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 15 | 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
| Delay expected |
Results Delay Reason
delay of data analysis
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 | 01 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 07 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049458
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