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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035167
Receipt No. R000040080
Official scientific title of the study Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Date of disclosure of the study information 2018/12/07
Last modified on 2018/12/07

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Basic information
Official scientific title of the study Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Title of the study (Brief title) Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Region
Japan

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

Objectives
Narrative objectives1 Effect of single intake of 3 dose(200mg,500mg,1000mg) 1,5-anhydro-D-fructose on postprandial 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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 1. 1st visit: Screening (Observation of blood sugar level after a meal)
2. 2nd visit: Single intake of a study food
(Observation of blood glucose levels on before food, after 30 minutes, 60 minutes, 90 minutes, and 120 minutes)
Interventions/Control_2 1. 1st visit: Screening (Observation of blood sugar level after a meal)
2. 2nd visit: Single intake of a study food
(Observation of blood glucose levels on before food, after 30 minutes, 60 minutes, 90 minutes, and 120 minutes)
Interventions/Control_3 1. 1st visit: Screening (Observation of blood sugar level after a meal)
2. 2nd visit: Single intake of a study food
(Observation of blood glucose levels on before food, after 30 minutes, 60 minutes, 90 minutes, and 120 minutes)
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. Subjects with fasting blood glucose level under 125mg/dl
4. The person who is relatively high in blood sugar level after a meal at the time of the prior screening examination
5. Serious disease (mental diseases such as diabetes, a heart trouble, a liver disease, renal disease, a malignant tumor and the depression) without the anamnesis
6. 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. Participants in other clinical trial
10. Other persons who were judged inappropriate by principal investigator
Target sample size 12

Research contact person
Name of lead principal investigator Kenichi Furihata
Organization P-One Clinic, Keikokai Medical Corporation.
Division name Clinic Director
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 Tatsuo Uetake
Organization CXwellness, Inc.
Division name CEO
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)

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
2018 Year 12 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 07 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040080

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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