UMIN-CTR Clinical Trial

Public title

Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.

Acronym

Examination of inhibitory effect of test drink on postprandial hyperglycemia.

Scientific Title

Pilot study of the effect of test drink in subjects with postprandial hyperglycemia.

Scientific Title:Acronym

Examination of inhibitory effect of test drink on postprandial hyperglycemia.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Examination of inhibitory effect of test drink containing plant extract on increase of postprandial blood glucose level.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Postprandial blood glucose level, change of blood glucose level

Key secondary outcomes

Area under the curve of blood glucose level, maximum blood glucose level

Study type

Interventional

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of water (single ingestion) - washout period - beverage containing plant extract (single ingestion)

Interventions/Control_2

Intake of beverage containing plant extract (single ingestion) - washout period - water (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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Healthy males and females from 20 to 64 years of age
2) Blood glucose level at postprandial 30 minitues is ranged from 130 mg/dL to 199 mg/dL
3) Priority is given to those with a blood glucose peak of 30 minutes

Key exclusion criteria

1) Subjects who routinely use health food containing large amount of participating component 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

24

Name of lead principal investigator

1st name
Middle name
Last name	Hirona Miura

Organization

Higashi shinjuku Clinic

Division name

Director

Zip code

Address

1-11-3 Okubo Shinjuku-ku Tokyo

TEL

03-6233-8581

Email

koike@meiseikai-cl.com

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

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

non-disclosure

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

05

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Twenty - four adult men and women with high blood glucose levels 30 minutes after a meal were given a single drink containing a plant extract and water, and the effect of suppressing an increase in postprandial blood glucose level was examined.
As a result, no significant difference was found between the botanical extract-containing beverage and the water in both the primary evaluation item and the secondary evaluation item.
Regarding safety, there were no adverse events in any of the subjects during this study, and there were no problems with safety.

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

02

Month

08

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

03

Month

05

Day

Last modified on

2018

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036073