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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028509
Receipt No. R000032626
Scientific Title A study for evaluating the effect of suppressing of blood glucose level after meals of the intake of food containing HYA on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial
Date of disclosure of the study information 2017/08/03
Last modified on 2017/10/27

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Basic information
Public title A study for evaluating the effect of suppressing of blood glucose level after meals of the intake of food containing HYA on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial
Acronym A study for evaluating the effect of suppressing of blood glucose level after meals of the intake of food containing HYA
Scientific Title A study for evaluating the effect of suppressing of blood glucose level after meals of the intake of food containing HYA on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial
Scientific Title:Acronym A study for evaluating the effect of suppressing of blood glucose level after meals of the intake of food containing HYA
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the dose-finding of effect of food containing HYA on postprandial hyperglycemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Area under the curve of plasma glucose levels
Key secondary outcomes Postprandial blood glucose, maximum plasma glucose levels, postprandial insulin levels

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of food without HYA (single ingestion) - washout period - food containing HYA (single ingestion)
Interventions/Control_2 Intake of food containing HYA (single ingestion) - washout period - food without HYA (single ingestion)
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
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) Males and females from 20 to 69 years of age
2) postprandial blood glucose levels are ranged from 140 mg/dL to 199 mg/dL
Key exclusion criteria 1) Subjects who routinely use health food containing large amount of unsaturated fatty acids or health food for diet
2) Subjects routinely taking medicine or health food which may influence glucose metabolism
3) Subjects who have body mass index (BMI) less than 18.5 kg/square meter or more than 30.0 kg/square meter
4) Subjects who have fasting blood glucose more than 126 mg/dL on preliminary examination
5) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
6) Subjects having possibilities for emerging allergy related to the current study
7) Subjects who are under medication or having a history of serious diseases for which medication was required
8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
10) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
12) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasunori Yonejima
Organization NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.
Division name Research and Development Division
Zip code
Address 35-3, Minamibiraki., Kamiueno-cho, Muko-shi Kyoto
TEL 075-921-5344
Email y.yonejima@nitto-ph.com

Public contact
1st name of contact person
1st name
Middle name
Last name Shinsuke Tsuji
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

Funding Source
Organization NITTO PHARMACEUTICAL INDUSTRIES 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
2017 Year 08 Month 03 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
2017 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2017 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032626

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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