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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043590
Receipt No. 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 2021/03/11

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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
Email 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
Email e-karita@morinagamik.co.jp

Sponsor
Institute Medical Corporation Chiseikai Tokyo Center Clinic
Institute
Department

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
Email 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 Preinitiation
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 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049774

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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