UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043084
Receipt number R000049188
Scientific Title A verification study of safety evaluation of excessive ingestion of NMN-containing food in humans: a randomized, double-blind, placebo-controlled, parallel study
Date of disclosure of the study information 2021/01/27
Last modified on 2021/06/02 18:53:13

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Basic information

Public title

A verification study of safety evaluation of excessive ingestion of NMN-containing food in humans: a randomized, double-blind, placebo-controlled, parallel study

Acronym

Safety evaluation of excess ingestion of NMN-containing food in humans.

Scientific Title

A verification study of safety evaluation of excessive ingestion of NMN-containing food in humans: a randomized, double-blind, placebo-controlled, parallel study

Scientific Title:Acronym

Safety evaluation of excess ingestion of NMN-containing food in humans.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Safety evaluation of more than five times ingestion of the recommended daily intake of the test food.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Physical examination
2. Urinalysis
3. Blood test
* Assess these tests at screening (before consumption) and at 2 and 4 weeks after consumption and 2 weeks after consumption completed.

Key secondary outcomes



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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of NMN-containing food once a day for 4 weeks.

Interventions/Control_2

Intake of placebo without NMN once 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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Males and females, aged 20 - 65 years old.
2)Subjects who are deagnosed as eligible to participate in the study by the physician

Key exclusion criteria

1)A medical history of malignant tumor, heart failure or myocardial infarction.
2) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3) Subjects who currently taking medications (including herbal medicines)
4) Subjects who are allergic to medications and/or the test food related products.
5) Subjects who are pregnant, breast-feeding, or planning to become pregnant.
6) Subjects who are judged as ineligible to participate in the study by the physician.

Target sample size

32


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Yamatsu

Organization

Pharma Foods International Co., Ltd.

Division name

Research and Development Department 1

Zip code

615-8245

Address

1-49 Goryo-Ohara, Nishikyo-ku, Kyoto

TEL

075-748-9829

Email

a-yamatsu@pharmafoods.co.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Ishida

Organization

Pharma Foods International Co., Ltd.

Division name

Research and Development Department 2

Zip code

615-8245

Address

1-49 Goryo-Ohara, Nishikyo-ku, Kyoto

TEL

075-748-9829

Homepage URL


Email

a-ishida@pharmafoods.co.jp


Sponsor or person

Institute

Pharma Foods International Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Mitsubishi Corporation Life Sciences Limited

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 committees of Yoga Allergy Clinic

Address

4-32-16, Yoga, Setagaya-ku, Tokyo, Japan

Tel

03-5491-4478

Email

jim@medipharma.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

2021 Year 01 Month 27 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

2020 Year 12 Month 18 Day

Date of IRB

2021 Year 01 Month 15 Day

Anticipated trial start date

2021 Year 01 Month 27 Day

Last follow-up date

2021 Year 03 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

2021 Year 01 Month 21 Day

Last modified on

2021 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049188


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name