UMIN-CTR Clinical Trial

Public title

Study of the effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol : an open-labeled pilot study

Acronym

The effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol.

Scientific Title

Study of the effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol : an open-labeled pilot study

Scientific Title:Acronym

The effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect on fasting blood glucose, serum Triglyceride, LDL-cholesterol under the consumption of HYA for 12 weeks

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fasting blood glucose level, Triglyceride level and LDL-cholesterol level at weeks 4, 8 and 12 ingestion

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of food containing HYA for 12 weeks, 1 package per day.

Interventions/Control_2

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) Males and females from 20 to 64 years of age
(2) Subjects falling under any of the following criteria
a. Fasting blood glucose levels are ranged from 100 mg/dL to 125 mg/dL
b. Serum Triglyceride levels are ranged from 120 mg/dL to 199 mg/dL
c. LDL-Cholesterol levels are ranged from 120 mg/dL to 159 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 who constantly use oral medication and/or functional foods which may affecting serum lipid levels, lipid metabolism and/or glycometabolism
(3) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(4) Subjects having possibilities for emerging allergy related to the current study
(5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(6) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
(7) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the current study by the investigator

Target sample size

40

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

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

NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

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

2015

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Intake of HYA-containing foods suggested possibility that the effect of the improving the fasting blood glucose in subjects with high BMI and fasting blood glucose level.
There was no problem in the safety of HYA-containing foods in this test conditions.

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

2015

Year

11

Month

26

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

11

Month

27

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=R000023052