UMIN-CTR Clinical Trial

Public title

Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract

Acronym

Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract

Scientific Title

Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract

Scientific Title:Acronym

Safety Evaluation of Long-Term Intake of a Test Food Containing Plant Extract

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 long-term intake (12 weeks) of a test food containing plant extract.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Existence and its contents of side effects: number of cases and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 4, Week 8, Week 12)

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) (SCR, Week 0, Week 4, Week 8, Week 12)
[2]Blood pressure, pulsation (SCR, Week 0, Week 4, Week 8, Week 12)
[3]Weight, body fat percentage, BMI (SCR, Week 0, Week 4, Week 8, Week 12)
[4]Hematologic test (SCR, Week 0, Week 4, Week 8, Week 12)
[5]Blood biochemical test (SCR, Week 0, Week 4, Week 8, Week 12)
[6]Urine analysis (SCR, Week 0, Week 4, Week 8, Week 12)
[7]Doctor's questions (SCR, Week 0, Week 4, Week 8, Week 12)

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

Study type

Interventional

Basic design

Parallel

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

Other

Interventions/Control_1

Oral intake of the test product (containing plant extract; 100mL in a day for 12 weeks)

Interventions/Control_2

Oral intake of the placebo product (not containing plant extract; 100mL in a day for 12 weeks)

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]Japanese males and females aged 20-65 years (estimated male-female rate of subjects is 1:1; the generation variability of subjects shall be avoided).
[2]Individuals whose BMI is over 18.5 and under 30.
[3]Individuals who are healthy and are not suffered from a chronic malady.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can come to the designated venue for this study and be inspected.
[6]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 who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[7]Individuals who experienced unpleasant feeling during blood drawing.
[8]Individuals who are sensitive to a test product or other foods, and medical products.
[9]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).
[10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[12]Individuals who are or are possibly, or are lactating.
[13]Individuals who participated in other clinical studies in the past 3 months.
[14]Individuals who are or whose family is engaged in healthy or functional foods.
[15]Individuals judged inappropriate for the study by the principal.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuhiro Sugimoto

Organization

Otsubokai Medical Corporation Tohto Bunkyo Hospital

Division name

Head

Zip code

Address

3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN

TEL

03-3831-2181

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

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

Ogawa & 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

2017

Year

03

Month

24

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

Terminated

Date of protocol fixation

2017

Year

03

Month

06

Day

Date of IRB

Anticipated trial start date

2017

Year

03

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

2017

Year

03

Month

24

Day

Last modified on

2017

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030565