UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043477 |
|---|---|
| Receipt number | R000049642 |
| 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 | 2021/03/01 |
| Last modified on | 2024/03/15 10:13:40 |
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Basic information
Public title
Evaluation of the postprandial blood glucose
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 effects of consumption of the test food on postprandial blood glucose of healthy Japanese subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incremental area under the curve (IAUC) of the blood glucose levels
Key secondary outcomes
1. The levels of maximum (Cmax) blood glucose
2. The blood glucose level 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: Food containing lactic acid bacteria
Period II: Placebo
Carbohydrate load: Trelan-G 75 g
Administration:
<Screening>After taking blood samples before intake, take the carbohydrate load within 10 minutes.
<Period I, Period II>After taking blood samples before intake, eat test food with a glass of water (approximately 200 mL). 30 minutes after eating test food, take the carbohydrate load within 10 minutes.
*The intervention sequence is Period I to Period II, and each food is single ingestion.
*Washout period is for one week or more.
Interventions/Control_2
Period I: Placebo
Period II: Food containing lactic acid bacteria
Carbohydrate load: Trelan-G 75 g
Administration:
<Screening>After taking blood samples before intake, take the carbohydrate load within 10 minutes.
<Period I, Period II>After taking blood samples before intake, eat test food with a glass of water (approximately 200 mL). 30 minutes after eating test food, take the carbohydrate load within 10 minutes.
*The intervention sequence is Period I to Period II, and each food is single ingestion.
*Washout period is for one week or 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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. Japanese
2. Female
3. Subjects 40 or over to under 80 years old
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects whose postprandial blood glucose level (Cmax) is 140 mg/dL to 199 mg/dL in the screening
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements.
6. Subjects who are allergic to medicines and/or the test food related products.
7. Subjects who are pregnant, lactation, or 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 or plan to enroll in another clinical trial during trial period
9. Subjects who are ineligibility to participate in the study based on the evaluation of the principal 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 Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
TEL
03-5793-3623
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Curves Japan 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
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
| 2021 | Year | 03 | Month | 01 | 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
44
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 | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 20 | 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 | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049642
