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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042445
Receipt No. R000048451
Scientific Title Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, crossover trial
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/17

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Basic information
Public title Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Acronym Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Scientific Title Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, crossover trial
Scientific Title:Acronym Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of consumption of the test food on postprandial blood glucose in healthy Japanese subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Maximum blood concentration (Cmax) of the blood glucose levels after the carbohydrate load
Key secondary outcomes 1. The incremental area under the curve (IAUC) of the blood glucose levels after the carbohydrate load

2. The blood glucose level after the carbohydrate load before eating the test food and at 30, 60, 90, and 120 minutes after eating the test food

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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Period I: Pakupakukoubokun
Period II: Placebo
Carbohydrate load: Rice (200 g)

After taking blood samples prior to the ingestion of test foods, take two packs of the test food or placebo with approximately 200 mL of water. Then, take the carbohydrate load within 10 minutes.

*Washout period is for one week and more
Interventions/Control_2 Period I: Placebo
Period II: Pakupakukoubokun
Carbohydrate load: Rice (200 g)

After taking blood samples prior to the ingestion of test foods, take two packs of the test food or placebo with approximately 200 mL of water. Then, take the carbohydrate load within 10 minutes.

*Washout period is for one week and more
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult subjects

2. Subjects who are judged as eligible to participate in the study by the physician

3. Subjects whose casual blood glucose level (Cmax) of 140 mg/dL to 199 mg/dL in the screening

4. Subjects whose casual blood glucose level (Cmax) in the screening are relatively high
Key exclusion criteria 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

5. Subjects currently taking medicines (include herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Takara
Organization Medical Corporation Seishinkai, Takara Clinic
Division name Director
Zip code 141-0022
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL 03-5793-3623
Email t-takara@takara-clinic.com

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Suzuki
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization MAINICHIEGAO. CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email IRB@takara-clinic.com

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 11 Day
Date of IRB
2020 Year 11 Month 11 Day
Anticipated trial start date
2020 Year 11 Month 17 Day
Last follow-up date
2021 Year 04 Month 03 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 11 Month 13 Day
Last modified on
2020 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048451

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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