UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035167
Receipt number R000040080
Scientific Title 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 2019/05/09 11:42:19

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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

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

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 or person

Institute

P-One Clinic, Keikokai Medical Corporation.

Institute

Department

Personal name



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

Value
https://center6.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