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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036707
Receipt No. R000041805
Scientific Title Study on postprandial blood glucose response a 1,5-anhydro-D-fructose intake in healthy subjects.
Date of disclosure of the study information 2019/05/10
Last modified on 2019/09/12

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Basic information
Public title Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects.
Acronym Study on postprandial blood glucose response a 1,5-anhydro-D-fructose intake in healthy subjects.
Scientific Title Study on postprandial blood glucose response a 1,5-anhydro-D-fructose intake in healthy subjects.
Scientific Title:Acronym Study on postprandial blood glucose response a 1,5-anhydro-D-fructose intake in healthy subjects.
Region
Japan

Condition
Condition Healty volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of test food on blood glucose level
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes postprandial blood glucose level(AUC)
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The two groups cross-over study
Interventions/Control_2 1 first visit: Pre-sleeving examination (observation of blood sugar level after meal load)
2 visits to the 2nd and third visits: Single intake of test food or placebo food
(Intake of test food or placebo food and observation of blood glucose level before and after 30 minutes, 60 minutes, 90 minutes and 120 minutes after meal loading)
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
61 years-old >
Gender Male and Female
Key inclusion criteria 1.The person who does not treat the disease
2.Adult aged from 20y to 60y,both sexes,The person who participates voluntarily
3.Subject whose BMI is 18.5 kg/m2 or more and less than 25 kg/m2
4.Subjects with fasting bllod glucose level under 125mg/dl
5.The person who is relatively high in blood sugar level after a meal at the time of the prior screening examination
6.Serious disease (mental diseases such as diabetes, a heart trouble, a liver disease, renal disease, a malignant tumor and the depression) without the anamnesis
7.The person who can maintain an everyday lifestyle during testing period constantly"
Key exclusion criteria 1.Person with a history of the past who treat a serious disease (mental diseases such as diabetes, a heart trouble, a liver disease, renal disease, a malignant tumor and the depression)
2.more than 6.5% of hemoglobin A1c (NGSP)
3.After a meal the blood sugar level of 120 minutes more than 200 mg/dL
4.The person whom alimentary system such as gastric resection has in an operation career
5.The person who cannot maintain an everyday lifestyle constantly
6.Person with the shift work, person with the graveyard shift
7.Food allergy for the test food, the drug allergy which are thought about
8.A pregnant woman, nursing girl and the person who hope for the pregnancy all over the study time
9.Paticipants in other clinical trial
10.Volunteers rejected participanting in this study by chif investigator"
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Furihata
Organization P-One Clinic, Keikokai Medical Corporation.
Division name Clinic Director
Zip code 192-0071
Address View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
TEL 042-625-5216
Email furihata@p1-clinic.or.jp

Public contact
Name of contact person
1st name Tatsuo
Middle name
Last name Uetake
Organization CXwellness, Inc.
Division name CEO
Zip code 103-0023
Address 516 Nihonbashinagatani Bldg.,3-1-6,Nihonbashihoncho, Chuo-ku, Tokyo,Japan.
TEL 03-6225-5601
Homepage URL
Email uetake@cx-wellness.com

Sponsor
Institute P-One Clinic, Keikokai Medical Corporation.
Institute
Department

Funding Source
Organization Dr's choice 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 EC of P-One Clinic, Keikokai Medical Corp
Address View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
Tel 042-625-5216
Email furihata@p1-clinic.or.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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 10 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
2019 Year 03 Month 28 Day
Date of IRB
2019 Year 04 Month 24 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2019 Year 06 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 10 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041805

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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