UMIN-CTR Clinical Trial

Public title

Safety of Overconsumption of a Test Food

Acronym

Safety of Overconsumption of a Test Food

Scientific Title

Safety of Overconsumption of a Test Food

Scientific Title:Acronym

Safety of Overconsumption of a Test Food

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines safety of overconsumption (4 weeks) of a test food.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .

Key secondary outcomes

*Secondary outcomes
[1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
[2]Blood pressure, pulsation (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
[3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
[4]Hematologic test (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
[5]Blood biochemical test (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
[6]Urine analysis (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .
[7]Doctor's questions (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food) .

*Other index
[1]Subject's diary (each day during the test period).

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

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test product (354mL in a day for 4 weeks)

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

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

[1]Males and females aged 20-65 years.
[2]Individuals who are healthy and have no chronic physical disease.
[3]Individuals whose fasting blood glucose is over 100mg/dL, and less than 110mg/dL or over 110mg/dL, less than 126mg/dL.
[4]Individuals whose BMI is over 18.5 and under 30.
[5]Individuals whose written informed consent has been obtained.
[6]Individuals who can come to the designated venue for this study and be inspected.
[7]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[5]Individuals who are a patient or have a history of or endocrine disease.
[6]Individuals whose fasting blood glucose is over 126mg/dL or HbA1c (NGSP) is over 6.5%.
[7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals who experienced unpleasant feeling during blood drawing.
[10]Individuals who are sensitive to a test product or other foods, and medical products.
[11]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent).
[12]Individuals who have a habit to intake a product similar with a test food.
[13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[15]Individuals who are or are possibly, or are lactating.
[16]Individuals who participated in other clinical studies in the past 3 months.
[17]Individuals who cannot refrain from eating between meals.
[18]Individuals who are or whose family is engaged in functional foods or cosmetics.
[19]Individuals judged inappropriate for the study by the principal.

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Mamoru Oki

Organization

Seishukai Medical Corporation Seishukai Hospital

Division name

Head

Zip code

Address

3-18-5 Matsugaya Taito-ku Tokyo 111-0036, JAPAN

TEL

03-3847-8866

Email

info@tes-h.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

Hakkaisan Brewery Co., Ltd.

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

02

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

01

Month

15

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

11

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

02

Month

08

Day

Last modified on

2018

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035617