UMIN-CTR Clinical Trial

Public title

A study on the effects of test food on glucose behavior in human

Acronym

A study on the effects of test food on glucose behavior in human

Scientific Title

A study on the effects of test food on glucose behavior in human

Scientific Title:Acronym

A study on the effects of test food on glucose behavior in human

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of test food on glucose behavior in human.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Blood glucose levels, persistently measured by FreeStyle Libre Sensor (Abbott).

Key secondary outcomes

Questionnaire : Sense of hunger
Glycometabolism : HbA1c, FBS
Liver function : ALT, AST, Gamma-GTP, Total Bilirubin, Albumin, ALP
Renal function : Serum Creatinine
Serum lipid : TC, TG, LDL-C, HDL-C, RLP-C
Anthropometry : Weight, Abdominal circumference, Blood pressure, Body fat percentage, Physical activity

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Consume one test food a day (for 3day)->Washout (for 4 days) -> Consume one placebo food a day (for 3day)

Interventions/Control_2

Consume one placebo food a day (for 3day)-> Washout (for 4 days) -> Consume one test food a day (for 3day)

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

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Healthy volunteer
2.Males and females aged between 20 and 59.
3. Subjects who receive adequate explanation for participation in this research and provide informed consent in writing by their own free will.
4. Subjects who can take certainly foods according to instructions, and understand how to use wearable blood glucose monitoring equipment and wearable physical activity meter.
Subjects who can write Life diary and Questionnaire.
5. Subjects who are judged suitable for this study by principal investigator and doctors.

Key exclusion criteria

1. Subjects with diabetes or borderline diabetes.
2. Subjects who fall under any of the following: ALT>200 IU/L, AST>200 IU/L, Gamma-GTP>200 IU/L, Total Bilirubin>2.0g/dl.
3. Subjects who are suspected acute and subacute hepatopathy.
4. Subjects with serious heart problems.
5. Subjects with renal dysfunction (serum creatinine > 2.0 mg/dL).
6. Subjects with tumor bearing.
7. Subjects who can't take medication according to instructions.
8. Subjects who had serious disease or have disease in treatment, and who are judged not to be suitable for this study.
9. Subjects with risk of allergy related to this study.
10. Subjects who have symptoms such as fever, sore throat, cough, diarrhea, vomiting etc and are suspected acute infectious diseases.
11. Subjects who participated in other clinical trials within 2 months.
12. Subjects who continuously take dietary fiber or supplements, foods for specified health use , that contain substances affecting blood glucose levels.
13. Subjects who are judged unsuitable for this study by principal investigator and doctors.

Target sample size

30

Name of lead principal investigator

1st name	Yasuhiro
Middle name
Last name	Nishizaki

Organization

Tokai University School of Medicine

Division name

Dept. of Clinical Health Science

Zip code

151-0053

Address

1-2-5 Yoyogi, Shibuya-ku, Tokyo, Japan Tokai University Tokyo Hospital

TEL

03-3370-2321

Email

y-nishizaki@tokai.ac.jp

Name of contact person

1st name	Yasuhiro
Middle name
Last name	Nishizaki

Organization

Tokai University School of Medicine

Division name

Dept. of Clinical Health Science

Zip code

151-0053

Address

1-2-5 Yoyogi, Shibuya-ku, Tokyo, Japan Tokai University Tokyo Hospital

TEL

03-3370-2321

Homepage URL

Email

y-nishizaki@tokai.ac.jp

Institute

Tokai University School of Medicine

Institute

Department

Personal name

Organization

Mizkan Holdings Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board for Clinical Research, Tokai University

Address

143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN

Tel

0463-93-1121

Email

tokai-rinsho@ml.tokai-u.jp

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

2019

Year

07

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

29

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

Recruitment status

Completed

Date of protocol fixation

2019

Year

07

Month

24

Day

Date of IRB

2019

Year

08

Month

01

Day

Anticipated trial start date

2019

Year

08

Month

01

Day

Last follow-up date

2020

Year

02

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

07

Month

24

Day

Last modified on

2020

Year

04

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042710