UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035481
Receipt number R000040224
Scientific Title Safety of Overconsumption of a Test Food
Date of disclosure of the study information 2019/01/08
Last modified on 2019/07/09 17:15:57

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Basic information

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

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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).

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 2, Week 4).
[2]Blood pressure, pulsation (Week 0, Week 2, Week 4).
[3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4).
[4]Hematologic test (Week 0, Week 2, Week 4).
[5]Blood biochemical test (Week 0, Week 2, Week 4).
[6]Urine analysis (Week 0, Week 2, Week 4).
[7]Anti-Aging QOL Common Questionnaire Anti-Aging QOL Common Questionnaire (Week 0, Week 2, Week 4).
[8]Doctor's questions (Week 0, Week 2, Week 4).

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test product (9 capsules in a day for 4 weeks).

Interventions/Control_2

Oral intake of the placebo product (9 capsules in a day for 4 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 20-60 years.
[2]Individuals who are healthy and do not have chronic physical disorders, including skin diseases.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can come to the designated venue for this study and be inspected.
[5]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 BMI is 18.5 - 30.0.
[7]Individuals whose systolic and diastolic blood pressures, and pulsation are over 140mmHg, 90mmHg, and 100 beats per minute, 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 excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[14]Individuals who are or are possibly, or are lactating.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals who are or whose family is engaged in functional foods or cosmetics.
[17]Individuals judged inappropriate for the study by the principal.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Ono

Organization

Ueno-Asagao Clinic

Division name

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Zip code

110-0015

Address

Head

TEL

+81-3-6240-1162

Email

t.ono@ueno-asagao.clinic


Public contact

Name of contact person

1st name Ryoma
Middle name
Last name Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-6-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Mizkan Holdings Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Address

1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN

Tel

+81-3-5816-0711

Email

i.takahashi@tes-h.co.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 12 Month 04 Day

Date of IRB

2018 Year 12 Month 06 Day

Anticipated trial start date

2019 Year 01 Month 09 Day

Last follow-up date

2019 Year 02 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 08 Day

Last modified on

2019 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040224


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name