UMIN-CTR Clinical Trial

Basic information
Public title	Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Acronym	Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Scientific Title	Study on postprandial blood glucose response 1,5-anhydro-D-fructose intake in healthy subjects, dose finding study
Scientific Title:Acronym	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
Last name of lead principal investigator	1st name Middle name Last name Kenichi Furihata
Organization	P-One Clinic, Keikokai Medical Corporation.
Division name	Clinic Director
Zip code
Address	View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo
TEL	042-625-5216
Email	furihata@p1-clinic.or.jp

Public contact
1st name of contact person	1st name Middle name Last name Tatsuo Uetake
Organization	CXwellness, Inc.
Division name	CEO
Zip code
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
Address
Tel
Email

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

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	2018 Year 11 Month 30 Day
Date of IRB	2018 Year 11 Month 30 Day
Anticipated trial start date	2018 Year 12 Month 08 Day
Last follow-up date	2018 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 07 Day
Last modified on	2019 Year 05 Month 09 Day

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