UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023496
Receipt number R000027065
Scientific Title A study for evaluating the effect 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 2016/08/04
Last modified on 2017/04/12 18:36:13

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Basic information

Public title

A study for evaluating the effect 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 the intake of food containing HYA

Scientific Title

A study for evaluating the effect 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 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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of food without HYA (single ingestion) - washout period - food containing low-dose HYA (single ingestion) - washout period - food containing high-dose HYA (single ingestion)

Interventions/Control_2

Intake of food containing low-dose HYA (single ingestion) - washout period - food containing high-dose HYA (single ingestion) - washout period - food without HYA (single ingestion)

Interventions/Control_3

Intake of food containing high -dose HYA (single ingestion) - washout period - food without HYA (single ingestion) - washout period - food containing low-dose HYA (single ingestion)

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 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

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

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 or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 08 Month 04 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Compared with the placebo, low- and high-dose HYA showed a significant suppress the AUC of plasma glucose levels, maximum plasma glucose levels and postprandial blood glucose.

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

2016 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 05 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

2016 Year 08 Month 04 Day

Last modified on

2017 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027065


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name