UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043590 |
|---|---|
| Receipt number | R000049774 |
| Scientific Title | Randomized, single-blind, standard food-controlled crossover study of the effects of test food intake on postprandial blood glucose |
| Date of disclosure of the study information | 2021/04/06 |
| Last modified on | 2021/11/09 16:37:51 |
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Basic information
Public title
Clinical trial for evaluation of effects on postprandial blood glucose levels of a test food
Acronym
Clinical trial for evaluation of effects on postprandial blood glucose levels of a test food
Scientific Title
Randomized, single-blind, standard food-controlled crossover study of the effects of test food intake on postprandial blood glucose
Scientific Title:Acronym
Clinical trial for evaluation of effects on postprandial blood glucose levels of a test food
Region
| Japan |
Condition
Condition
Adults who tend to have high blood glucose levels
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of test food on postprandial blood glucose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of postprandial blood glucose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of placebo food, washout period for 2 weeks, single ingestion of test food.
Interventions/Control_2
Single ingestion of test food, washout period for 2 weeks, single ingestion of placebo food.
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) Subjects aged 20 or more and less than 65.
2) Subjects who meet any of the following criteria in the preliminary survey.
i) Fasting blood glucose level is 100 mg/dL or more and less than 125 mg/dL.
ii) 1-hour blood glucose level in 75-g oral glucose tolerance test (75 g OGTT) is 180 mg/dL or more.
iii) 2-hour blood glucose level in the 75 g OGTT is 140 mg/dL or more and less than 200 mg/dL.
iv) HbA1c value is 5.6 % or more and less than 6.5 %.
Key exclusion criteria
1) Subjects who exhibit allergic symptoms due to intake of milk or soybean-derived ingredients.
2) Subjects who donated/collected blood components or 200 mL or more of blood in the past 1 month, or who donated/collected 400 mL or more of blood on the past 4 months.
3) Subjects who meet both of the following criteria in the preliminary survey.
i) HbA1c value is 6.5 % or more.
ii) Fasting blood glucose level is 126 mg/dL or more, or 75 g OGTT 2-hour blood glucose level is 200 mg/dL or more.
4) Subjects who have been diagnosed with diabetes.
5) Subjects taking medications that may affect blood glucose levels.
6) Subjects who plan to participate in other clinical trials during the trial period.
7) Subjects who are under medical treatment of diseases in liver, kidneys, heart, lungs, digestive system, blood, endocrine and metabolic systems, or who have serious medical history of those diseases.
8) Others who are judged by the investigator to be inappropriate as participants in this test.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
Medical Corporation Chiseikai Tokyo Center Clinic
Division name
Internal Medicine
Zip code
103-0028
Address
KT Bldg, 2F, 1-1-8 Taesu, Chuo-ku, Tokyo 103-0028, JAPAN
TEL
03-3276-6935
nagashima_hirotaka@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Kokubo |
Organization
Morinaga Milk Industry Co., LTD.
Division name
R&D Division Wellness&Nutrition Science Institute
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-city, Kanagawa Pref. Japan
TEL
046-252-3057
Homepage URL
e-karita@morinagamik.co.jp
Sponsor or person
Institute
Medical Corporation Chiseikai Tokyo Center Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Japan Conference of Clinical Research
Address
1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo 171-0022,Japan
Tel
03-6868-7022
jccr-info@jccr.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
医療法人社団知正会東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 06 | 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
| 2021 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 17 | 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 | 11 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049774
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| Registered date | File name |
| Research case data | |
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