UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046972
Receipt number R000053540
Scientific Title A single arm study to assess the safety of high dose intake of the test food
Date of disclosure of the study information 2022/05/17
Last modified on 2023/02/23 10:08:35

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Basic information

Public title

A study of safety of high dose intake of the test food

Acronym

A study of safety of high dose intake of the test food

Scientific Title

A single arm study to assess the safety of high dose intake of the test food

Scientific Title:Acronym

A study of safety of high dose intake of the test food

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The safety of high dose intake of the test food in human

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood test
Urinalysis
Physical condition diary

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral intake of the test food (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



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Healthy males and females aged 18 to less than 75 years old.
2) Subjects who are capable of understanding the study, and those who can give written informed consents.

Key exclusion criteria

1) Subjects who are allergic to products related to the test material of this study.
2) Subjects who are addicted to alcohol or has an extremely irregular dietary habit.
3) Subjects who take drugs, quasi-drugs, dietary supplements, health foods or something other which possibly have effects on this study.
4) Subjects who are pregnant or breastfeeding, or desires to get pregnant during the study period.
5) Subjects who are judged unsuitable for this study by principal investigator.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masataka
Middle name
Last name Saito

Organization

Kagawa Nutrition University

Division name

Laboratory of Food Science and Technology

Zip code

350-0288

Address

3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan

TEL

049-282-3729

Email

msaito@eiyo.ac.jp


Public contact

Name of contact person

1st name Yuko
Middle name
Last name Nagata

Organization

Momoya Co., Ltd.

Division name

Research & Development Division

Zip code

344-8522

Address

410 Akanuma, Kasukabe, Saitama 344-8522, Japan

TEL

048-720-8352

Homepage URL


Email

y.nagata@momoya.co.jp


Sponsor or person

Institute

Momoya Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Momoya Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kagawa Nutrition University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Human Research Ethics Committee of Kagawa Nutrition University

Address

3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan

Tel

049-289-6041

Email

kenshien@eiyo.ac.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

女子栄養大学(埼玉県)
Kagawa Nutrition University (Saitama)
株式会社桃屋(埼玉県)
Momoya Co., Ltd. (Saitama)


Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 17 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

10

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

2022 Year 02 Month 22 Day

Date of IRB

2022 Year 03 Month 16 Day

Anticipated trial start date

2022 Year 05 Month 18 Day

Last follow-up date

2023 Year 05 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 02 Month 22 Day

Last modified on

2023 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053540


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name